Mis crosslink apparatus and methods for spinal implant

ABSTRACT

A spinal implant provides support for desired parts of the spine. The spinal implant includes a pair of elongated members and a variable length cross-link. A variable length cross-link device may include a fixed portion having a receiver portion for attachment to a first elongated member a transverse portion, and an adjustable portion having a receiver portion for attachment to a second elongated member and a transverse portion engaging member. Inserting the transverse portion of the fixed portion into the engaging portion of the adjustable portion may form a cross-link for stabilizing motion between two elongated members. Engaging the adjustable portion at a selected point on the transverse portion establishes a length selected by the surgeon. The surgical procedure may use minimally invasive surgery or non-minimally invasive surgery, as desired. Components may be inserted through sleeves attached to various coupling devices, or may be inserted and guided along wires.

CROSS REFERENCE TO RELATED APPLICATION(S)

This application is a continuation of U.S. patent application Ser. No.11/839,406, filed Aug. 15, 2007, now allowed, entitled “MIS CROSSLINKAPPARATUS AND METHODS FOR SPINAL IMPLANT,” which is fully incorporatedby reference herein.

TECHNICAL FIELD

The present disclosure relates generally to spinal implants. Moreparticularly,the disclosure concerns articulating variable cross-link ortransverse connecting devices useful in spinal implants.

BACKGROUND

Modern spine surgery often involves the use of spinal implants tocorrect or treat various spine disorders and/or to support the spine.Spinal implants may help, for example, to stabilize the spine, correctdeformities of the spine, facilitate fusion, or treat spinal fractures.Typical spinal implants may include rigid (i.e., via a fusion procedure)support for the affected regions of the spine. Such spinal implantslimit movement in the affected regions (e.g., in a fused region) invirtually all directions.

Prior spinal implants typically use elongated members to support partsof the spine. The rods usually do not provide much protection againsttorsional forces or movement. Efforts have been made to address thatconcern. One solution is to connect elongated members using cross-linkdevices. Conventional cross-link devices, however, have many weaknesses.For example, conventional cross-link devices are inflexible and providea very limited range of motion. Thus, a surgeon using conventionalcross-link devices cannot readily adjust the spinal implant according toeach patient's needs and anatomy. Furthermore, because a surgeon has toadjust a relatively large number of fasteners during the surgery, theinstallation of a conventional cross-link device can be time consuming,which is highly undesirable.

SUMMARY

One embodiment of the present disclosure is directed to a method forpercutaneously attaching a cross link in a spine stabilization system ina minimally invasive spine stabilization procedure by guiding a fixedportion of a cross-link through an incision to an elongated memberpositioned on a first side of the spine, and connecting the fixedportion to the elongated member, guiding an adjustable portion throughan incision to an elongated member positioned on a second side of thespine and connecting the adjustable portion to the second elongatedmember, and advancing a transverse portion of the fixed portion aselected length in the adjustable portion to form a cross-link having aselected length. In one embodiment the step of guiding a fixed portionof a cross-link may include connecting the fixed portion to the distalend of a sleeve; and advancing the distal end of the sleeve to positionthe fixed portion on the first elongated member. In one embodiment thestep of guiding an adjustable portion of a cross-link may includeconnecting the adjustable portion to the distal end of a sleeve andadvancing the distal end of the sleeve to position the adjustableportion on the second elongated member. In one embodiment the step ofconnecting the adjustable portion to the distal end of a sleeve mayinclude threadably engaging the adjustable portion to the sleeve. In oneembodiment the step of guiding a fixed portion of a cross-link mayinclude threadably engaging the fixed portion to the distal end of apositioning tool, and advancing the distal end of the positioning toolto position the fixed portion on the first elongated member. In oneembodiment the step of guiding a fixed portion of a cross-link mayinclude inserting a guide wire into a cannulated passage in the fixedportion, advancing the guide wire into a first incision in the body,advancing the guide wire near an elongated member and advancing thefixed portion into the body via the guide wire. In one embodiment theguide wire remains stationary and the fixed portion advances along theguide wire. In one embodiment the guide wire comprises one or morefeatures for engaging the fixed portion and the fixed portion isadvanced by advancing a portion of the guide wire through the body. Inone embodiment the step of advancing a transverse portion of the fixedportion a selected length in the adjustable portion may includeinserting a portion of the guide wire in a cannulated passage in theadjustable portion, and advancing the transverse portion of the fixedportion into the adjustable portion via the guide wire. In oneembodiment the guide wire remains stationary and one or more of thefixed portion and adjustable portion advances along the guide wire. Inone embodiment the method may include advancing a portion of the guidewire out a second incision and advancing an adjustable portion into thebody via the guide wire, using a cannulated passage in the adjustableportion. In one embodiment the step of connecting the adjustable portionto the second elongated member may include advancing a distal end of adriver through the sleeve, connecting a driver to a tool portion of aconnection member on the adjustable portion, and rotating the driver,wherein the connection member is advanced to connect the adjustablemember to the elongated member. In one embodiment the step of advancinga transverse portion of the fixed portion a selected length in theadjustable portion may include engaging, by the adjustable portion, oneor more engagement features on the transverse portion. In one embodimentthe one or more engagement features comprises a helically wound threadon the transverse portion and the transverse portion advances a selectedlength in the adjustable portion by rotating a bearing comprising acomplementary thread engaged with the helically wound thread. In oneembodiment the one or more engagement features comprises a series ofnotches on the transverse portion, and the transverse portion advances aselected length in the adjustable portion by pulling the end of thetransverse portion, and a ratchet in the adjustable portion engages oneor more of the series of notches. In one embodiment the one or moreengagement features comprises a series of teeth on the transverseportion, and the transverse portion advances a selected length in theadjustable portion by rotating a gear on the transverse portion meshedwith one or more of the teeth.

In one embodiment, a method for stabilizing a portion of a spine usingminimally invasive surgery may include affixing a first elongated memberpercutaneously to one or more vertebrae on a first side of the spine,affixing a second elongated member percutaneously to the one or morevertebrae on a second side of the spine, connecting a fixed portion of across-link to the distal end of a first positioning tool, advancing thefixed portion percutaneously to a position on the first elongatedmember, connecting a receiver portion of the fixed portion to the firstelongated member, connecting a portion of an adjustable portion of thecross-link to the distal end of a sleeve, advancing the fixed portionpercutaneously to a position on the second elongated member, connectingthe adjustable portion to the second elongated member, advancing thetransverse portion a selected distance in the adjustable portion, andengaging one or more engagement features to couple the adjustableportion and the fixed portion. In one embodiment the step of connectinga fixed portion of a cross-link to the distal end of the positioningtool includes threadably engaging the fixed portion to the positioningtool. In one embodiment the step of connecting an adjustable portion ofa cross-link to the distal end of the sleeve includes threadablyengaging the adjustable portion to the sleeve. In one embodiment thetransverse portion comprises a helically wound thread and the adjustableportion comprises a complementary threaded bearing, and advancing thetransverse portion of the fixed portion includes rotating the threadedbearing. In one embodiment the transverse portion comprises a series ofnotches and the adjustable portion comprises a ratchet, and advancingthe transverse portion of the fixed portion comprises pulling thetransverse portion through the adjustable portion such that the ratchetengages one or more notches. In one embodiment the transverse portioncomprises a series of teeth and the adjustable portion comprises a gear,and advancing the transverse portion of the fixed portion comprisesrotating the gear engaged with one or more teeth.

In one embodiment, a wire-guided system for stabilizing a portion of aspine using percutaneous procedures may include a guide wire configuredfor insertion into one or more cannulated passages, and configured foradvancement near an elongated member, an adjustable portion having acannulated passage for detachable engagement of the guide wire, and afixed portion having a cannulated passage for detachable engagement of aguide wire, and configured for connection to a second elongated memberaffixed to vertebrae on a second side of the spine and coupling to theadjustable portion to form the cross-link.

In one embodiment, a system for stabilizing a portion of a spine usingpercutaneous procedures may include a first elongated member, a secondelongated member, an adjustable portion, a fixed portion, a sleeve fordetachable connection to the adjustable portion, and a positioning toolfor detachable connection to the fixed portion. The elongated membersmay be affixed to either side of the spine. The adjustable portion maycouple to the transverse portion. In one embodiment the positioning toolmay detachably connect to the fixed portion, advance through an incisionto the second elongated member, and advance a transverse portion of thefixed portion into the adjustable portion to establish a selected lengthof the cross-link. In one embodiment the sleeve may connect to theadjustable portion and advance the adjustable portion through anincision to the first elongated member.

Embodiments of the present disclosure may be implanted using existinginstrumentation and tools. Embodiments of the present disclosure may beimplanted using MIS procedures. Embodiments of the present disclosuremay provide additional rigidity to a spine stabilization system.Embodiments of the present disclosure may be implanted using a minimumnumber of fasteners. Embodiments of the present disclosure may beimplanted using various techniques including advancing into the bodyusing sleeves and/or guide wires.

These, and other, aspects of the disclosure will be better appreciatedand understood when considered in conjunction with the followingdescription and the accompanying drawings. The following description,while indicating various embodiments of the disclosure and numerousspecific details thereof, is given by way of illustration and not oflimitation. Many substitutions, modifications, additions orrearrangements may be made within the scope of the disclosure, and thedisclosure includes all such substitutions, modifications, additions orrearrangements.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the present disclosure and theadvantages thereof may be acquired by referring to the followingdescription, taken in conjunction with the accompanying drawings inwhich like reference numbers indicate like features and wherein:

FIG. 1 depicts a perspective view of an embodiment of a spinalstabilization system.

FIG. 2 depicts a perspective view of an embodiment of a bone fastenerassembly.

FIG. 3 depicts a perspective view of an embodiment of a bone fastener.

FIGS. 4A and 4B depict perspective views of embodiments of bone fastenerassembly rings.

FIG. 5 depicts a perspective view of an embodiment of a bone fastenerassembly collar.

FIG. 6 depicts a cross-sectional view of an embodiment of a bonefastener assembly.

FIG. 7 depicts a perspective view of an embodiment of a bone fastenerassembly.

FIGS. 8A-8C depict schematic views of a method of positioning a ring ina collar of a bone fastener assembly.

FIGS. 9A-9C depict schematic views of a method of positioning a ring ina collar of a bone fastener assembly.

FIGS. 10A and 10B depict schematic views of positioning a bone fastenerin a ring and collar to form a bone fastener assembly.

FIG. 11 depicts a front view of an embodiment of a bone fastenerassembly with a collar that allows for angulation of a bone fastenerrelative to the collar in a conical range of motion that is symmetricalrelative to an axis that passes through a central axis of the collar anda central axis of a bone fastener.

FIG. 12A depicts a front view of an embodiment of a bone fastenerassembly with a collar that allows for angulation of a bone fastenerrelative to the collar in a conical range of motion that is notsymmetrical relative to an axis that passes through a central axis ofthe collar and a central axis of a bone fastener. The collar allowsadditional lateral bias relative to a non-biased collar.

FIG. 12B depicts a side view of an embodiment of a bone fastenerassembly with a collar that allows for angulation of a bone fastenerrelative to the collar in a conical range of motion that is notsymmetrical relative to an axis that passes through a central axis ofthe collar and a central axis of a bone fastener. The collar allowsadditional caudal or cephalid bias relative to a non-biased collar.

FIGS. 13A and 13B depict superior views of a vertebral body having oneembodiment of a spinal stabilization system implanted thereon, thespinal stabilization system having adjustable bone fastener assemblies.

FIG. 14 depicts a perspective view of an embodiment of a closure member.

FIG. 15 depicts a cross-sectional representation of the closure membertaken substantially along plane 15-15 indicated in FIG. 14.

FIG. 16 depicts a perspective view of an embodiment of a portion of aspinal stabilization system.

FIG. 17A depicts a cross-sectional representation of an embodiment of aspinal stabilization system.

FIG. 17B depicts a detailed view of a portion of FIG. 17A.

FIGS. 18A depicts a cross-sectional representation of an embodiment of aspinal stabilization system.

FIG. 18B depicts a detailed view of a portion of FIG. 18A.

FIG. 19 depicts a perspective view of an embodiment of a targetingneedle.

FIG. 20 depicts a perspective view of an outer housing of a targetingneedle.

FIG. 21 depicts a perspective view of an embodiment of a member of atargeting needle,

FIG. 22 depicts a perspective view of an embodiment of a guide wire.

FIG. 23 depicts a perspective view of an embodiment of a guide wire.

FIG. 24 depicts a perspective view of an embodiment of a bone awl.

FIG. 25 depicts a perspective view of an embodiment of a bone tap.

FIG. 26 depicts a perspective view of an embodiment of a multi-channelsleeve.

FIG. 27 depicts a top view of an embodiment of a multi-channel sleevewith a bone fastener assembly coupled to the sleeve.

FIG. 28 depicts a cross-sectional representation of a portion of thesleeve with the bone fastener assembly taken substantially along line28-28 of FIG. 27.

FIG. 29 depicts a cross-sectional representation of a portion of thesleeve with the bone fastener assembly taken substantially along line29-29 of FIG. 27.

FIG. 30 depicts a perspective view of an embodiment of a single-channelsleeve.

FIG. 31 depicts a perspective view of an embodiment of a sleeve duringconnection of the sleeve to a collar of a bone fastener assembly.

FIG. 31A depicts a detailed view of a portion of FIG. 31.

FIG. 32 depicts a partial cross-sectional representation of anembodiment of a sleeve coupled to a collar of a bone fastener assembly.

FIG. 33 depicts a partial cross-sectional representation of anembodiment of a sleeve coupled to a collar of a bone fastener assembly.

FIG. 34 depicts a partial cross-sectional representation of anembodiment of a sleeve coupled to a collar of a bone fastener assembly.

FIG. 35 depicts a partial cross-sectional representation of anembodiment of a sleeve coupled to a collar of a bone fastener assembly.

FIG. 36 depicts top view representation of an embodiment of a collar.

FIG. 37 depicts a partial cross-sectional representation of anembodiment of a sleeve coupled to an embodiment of a collar of a bonefastener assembly, such as the collar depicted in FIG. 36.

FIG. 38 depicts a top view representation of an embodiment of a collar.

FIG. 39 depicts a partial cross-sectional representation of anembodiment of a sleeve coupled to an embodiment of a collar of a bonefastener assembly, such as the collar depicted in FIG. 38.

FIG. 40 depicts a partial cross-sectional view of an embodiment of asleeve with an inner sleeve.

FIG. 41 depicts a partial cross-sectional representation of anembodiment of a sleeve coupled to a collar of a bone fastener assembly.

FIG. 42 depicts a partial cross-sectional representation of anembodiment of a sleeve coupled to a collar of a bone fastener assembly.

FIG. 43 depicts a partial cross-sectional representation of anembodiment of a sleeve coupled to a collar of a bone fastener assembly.

FIG. 44 depicts a cross-sectional representation of an embodiment of ahinged sleeve coupled to a collar of a bone fastener assembly.

FIG. 45 depicts a cross-sectional representation of an embodiment of ahinged sleeve coupled to a collar of a bone fastener assembly.

FIG. 46 depicts a schematic representation of sleeve embodiments coupledto collars of a spinal stabilization system.

FIG. 47 depicts a schematic representation of sleeve embodiments withconnections that allow relative movement of portions of a sleeve.

FIG. 48 depicts a perspective view of an embodiment of sleeves coupledto bone fastener assemblies.

FIG. 49 depicts a perspective view of an embodiment of sleeves that arecoupled to bone fastener assemblies.

FIG. 50 depicts a schematic view of sleeve embodiments that are coupledto one embodiment of a frame.

FIG. 51 depicts a perspective view of an embodiment of a driver coupledto a bone fastener and a sleeve.

FIG. 52 depicts a partial cross-sectional view of an embodiment of abone fastener and collar coupled to a driver positioned in a dilator.

FIG. 53 depicts a perspective view of an embodiment of a tissue wedge.

FIG. 54 depicts a perspective view of an embodiment of an estimatingtool.

FIG. 55 depicts a perspective view of an embodiment of an estimatingtool.

FIG. 56 depicts a perspective view of an embodiment of an estimatingtool.

FIG. 57 depicts a perspective view of a tool designed to position anelongated member proximate vertebrae.

FIG. 58 depicts a perspective view of a seater for placing an elongatedmember proximate vertebrae.

FIGS. 59A and 59B depict perspective views of a tool designed toposition a closure member in a collar coupled to a bone fastener.

FIGS. 60A and 60B depict perspective views of a tool designed toposition a closure member in a collar coupled to a bone fastener.

FIG. 61 depicts an embodiment of a counter torque wrench coupled to asleeve.

FIG. 62 depicts an embodiment of a counter torque wrench.

FIG. 63 depicts a schematic view of the counter torque wrench shown inFIG. 62 coupled to an elongated member.

FIGS. 64A-64E depict schematic views of guide wire placement during aminimally invasive spinal stabilization procedure.

FIGS. 65A-65D depict schematic views of tissue dilation during aminimally invasive spinal stabilization procedure.

FIGS. 66A-66F depict schematic views of vertebra preparation forreceiving a bone fastener assembly during a minimally invasive spinalstabilization procedure.

FIGS. 67A-67D depict schematic views of insertion of a sleeve and bonefastener assembly during a minimally invasive spinal stabilizationprocedure.

FIGS. 68A-68D depict schematic views of tissue plane creation during aminimally invasive spinal stabilization procedure.

FIG. 69 depicts an embodiment of a tissue wedge.

FIGS. 70A-70D depict schematic views of placement of a sleeve and a bonefastener assembly in second vertebra during a minimally invasive spinalstabilization procedure.

FIG. 71 depicts a tissue plane between adjacent vertebrae with anchoredsleeves crossing at the surface of the skin.

FIG. 72 depicts an embodiment of an elongated member.

FIG. 73 depicts an embodiment of an elongated member.

FIG. 74 depicts an embodiment of an elongated member.

FIG. 75 depicts an embodiment of an elongated member.

FIGS. 76A-76D depict schematic views of elongated member placementduring a minimally invasive spinal stabilization.

FIG. 77 depicts a perspective view of a distal portion of a two-prongeddriver.

FIGS. 78A-78D depict schematic views of a sleeve removal during aminimally invasive spinal stabilization procedure.

FIGS. 79A-79E depict schematic views of elongated member placement insleeves for a multi-level spinal stabilization system.

FIGS. 80A-80C depict schematic views of bone fastener assemblies coupledto sleeves.

FIG. 81 depicts a perspective view of a bone fastener used in aninvasive procedure.

FIGS. 82A and 82B depict a perspective view and a close-up end view ofone embodiment of a spine stabilization system.

FIG. 83 depicts a perspective view of one embodiment of a portion of aspine stabilization system.

FIG. 84 depicts a perspective view of one embodiment of a cross-link,

FIG. 85A depicts a cross-sectional side view of a one embodiment of across-link.

FIG. 85B depicts a cross-sectional end view of one embodiment of across-link.

FIG. 86 depicts a perspective view of one embodiment of a cross-link.

FIG. 87 depicts a side view of one embodiment of a cross-link.

FIG. 88 depicts a posterior view of one embodiment of a spinestabilization system.

FIG. 89 depicts a superior view of one embodiment of a cross-link devicepositioned in a body, illustrating one embodiment of a method forimplanting a cross-link in a body.

FIG. 90A depicts a cross-section view of one embodiment of a guide wirefor use with one embodiment of a cross-link.

FIG. 90B depicts a cross-section view of one embodiment of a guide wirefor use with one embodiment of a cross-link.

FIGS. 91A, 91B, and 91C depict perspective views of one embodiment of aportion of a spinal fixation system.

FIGS. 92A and 92B depict views of one embodiment of a system useful forpositioning portions of a spinal fixation system.

FIGS. 93A and 93B depict views of one embodiment of a system useful forpositioning cross-links along a spine.

FIG. 94 depicts a side view of one embodiment useful for implantingportions of a spinal stabilization system.

DETAILED DESCRIPTION

The disclosure and he various features and advantageous details thereofare explained more fully with reference to the non-limiting embodimentsthat are illustrated in the accompanying drawings and detailed in thefollowing description. Descriptions of well known starting materials,processing techniques, components and equipment are omitted so as not tounnecessarily obscure the disclosure in detail. Skilled artisans shouldunderstand, however, that the detailed description and the specificexamples, while disclosing preferred embodiments of the disclosure, aregiven by way of illustration only and not by way of limitation. Varioussubstitutions, modifications, additions or rearrangements within thescope of the underlying inventive concept(s) will become apparent tothose skilled in the art after reading this disclosure.

A spinal stabilization system may be installed in a patient to stabilizea portion of a spine. Spinal stabilization may be used, but is notlimited to use, in patients having degenerative disc disease, spinalstenosis, spondylolisthesis, pseudoarthrosis, and/or spinal deformities;in patients having fracture or other vertebral trauma; and in patientsafter tumor resection. A spinal stabilization system may be installedusing a minimally invasive procedure. An instrumentation set may includeinstruments and spinal stabilization system components for forming aspinal stabilization system in a patient.

A minimally invasive procedure may be used to limit an amount of traumato soft tissue surrounding vertebrae that are to be stabilized. In someembodiments, the natural flexibility of skin and soft tissue may be usedto limit the length and/or depth of an incision or incisions neededduring the stabilization procedure. Minimally invasive procedures mayprovide limited direct visibility in vivo. Forming a spinalstabilization system using a minimally invasive procedure may includeusing tools to position system components in the body,

A minimally invasive procedure may be performed after installation ofone or more spinal implants in a patient. The spinal implant or spinalimplants may be inserted using an anterior procedure, posterior and/or alateral procedure. The patient may be turned and a minimally invasiveprocedure may be used to install a posterior spinal stabilizationsystem. A minimally invasive procedure for stabilizing the spine may beperformed without prior insertion of one or more spinal implants in somepatients. In some patients, a minimally invasive procedure may be usedto install a spinal stabilization system after one or more spinalimplants are inserted using a posterior spinal approach.

A spinal stabilization system may be used to achieve rigid pediclefixation while minimizing the amount of damage to surrounding tissue. Insome embodiments, a spinal stabilization system may be used to providestability to two adjacent vertebrae (i.e., one vertebral level). Aspinal stabilization system may include two elongated members affixed toadjacent vertebrae and positioned on either side of the spine. One bonefastener assembly may be positioned in each of the vertebrae to bestabilized. An elongated member may be coupled and secured to two ormore bone fastener assemblies. Across-link may be coupled to theelongated members. As used herein, “coupled” components may directlycontact each other or may be separated by one or more interveningmembers. In some embodiments, a single spinal stabilization system maybe installed in a patient.

Embodiments of the spinal stabilization system disclosed herein areparticularly useful for minimally invasive surgery (MIS) procedureswhich have many advantages. For example, minimally invasive proceduresmay reduce trauma to soft tissue surrounding vertebrae that are to bestabilized. Only a small opening may need to be made in a patient. Forexample, a surgical procedure may be performed through a 2 cm to 4 cmincision formed in the skin of the patient. In some embodiments, anincision may be above and substantially between the vertebrae to bestabilized. In some embodiments, an incision may be above and betweenthe vertebrae to be stabilized. In some embodiments, an incision may beabove and substantially halfway between the vertebrae to be stabilized.Dilators, a targeting needle, and/or a tissue wedge may be used toprovide access to the vertebrae to be stabilized without the need toform an incision with a scalpel through muscle and other tissue betweenthe vertebrae to be stabilized. A minimally invasive procedure mayreduce an amount of post-operative pain felt by a patient as compared toinvasive spinal stabilization procedures. A minimally invasive proceduremay reduce recovery time for the patient as compared to invasive spinalprocedures.

Spinal stabilization systems may be used to correct problems in lumbar,thoracic, and/or cervical portions of a spine. Various embodiments of aspinal stabilization system may be used from the Cl vertebra to thesacrum. For example, a spinal stabilization system may be implantedposterior to the spine to maintain distraction between adjacentvertebral bodies in a lumbar portion of the spine.

Embodiments of the disclosure may be particularly useful for stabilizingportions of the spine and may be implanted using MIS procedures and thusit is in this context that embodiments of the disclosure may bedescribed. It will be appreciated, however, that embodiments of thesystems and methods of the present disclosure may be applicable forstabilizing other areas of the body.

Cross-link devices allow transverse support of the spine in fusionprocedures. More specifically, embodiments of the cross-link devices maybe useful for limiting or eliminating undesired motion (e.g., torsionalmovement) in a spinal fusion implant. In some applications, variablelength cross-link devices may enable a surgeon to extend a fused portionof the spine to additional levels. In such cases, the surgeon may useextended elongated members, and use cross-link devices to provideselective support. The novel cross-link devices may provide severaladvantages over conventional devices, as persons of ordinary skill inthe art who have the benefit of the description of the presentdisclosure will appreciate.

Components of spinal stabilization systems may be made of materialsincluding, but not limited to, titanium, titanium alloys, stainlesssteel, ceramics, and/or polymers. Some components of a spinalstabilization system may be autoclaved and/or chemically sterilized.Components that may not be autoclaved and/or chemically sterilized maybe made of sterile materials. Components made of sterile materials maybe placed in working relation to other sterile components duringassembly of a spinal stabilization system.

Reference is now made in detail to the exemplary embodiments of thedisclosure, examples of which are illustrated in the accompanyingdrawings. Wherever possible, the same reference numbers will be usedthroughout the drawings to refer to the same or like parts (elements.)

FIG. 1 depicts one embodiment of elongated member 104 coupled to bonefastener assemblies 102 that may be implanted on either side of a spineusing a minimally invasive surgical procedure. In some embodiments,multi-level spinal stabilization systems may include additional bonefastener assemblies 102 to couple to one or more other vertebrae.

FIG. 2 depicts a perspective view of bone fastener assembly 102. FIG. 3,FIGS. 4A and 4B, and FIG. 5 depict embodiments of components of bonefastener assembly 102 including bone fastener 108 (shown in FIG. 3),ring 110 (shown in FIGS. 4A and 4B), and collar 112 (shown in FIG. 5).Bone fastener 108 may couple bone fastener assembly 102 to a vertebra.Ring 110 may be positioned between a head of bone fastener 108 andcollar 112.

A bone fastener may be, but is not limited to, a bone screw, a ringshank fastener, a barb, a nail, a brad, or a trocar. Bone fastenersand/or bone fastener assemblies may be provided in various lengths in aninstrumentation set to accommodate variability in vertebral bodies. Forexample, an instrumentation set for stabilizing vertebrae in a lumbarregion of the spine may include bone fastener assemblies with lengthsranging from about 30 mm to about 75 mm in 5 mm increments. A bonefastener assembly may be stamped with indicia (i.e., printing on a sideof collar 112). In some embodiments, a bone fastener assembly or a bonefastener may be color-coded to indicate a length of the bone fastener.In certain embodiments, a bone fastener with a 30 mm thread length mayhave a magenta color, a bone fastener with a 35 mm thread length mayhave an orange color, and a bone fastener with a 55 mm thread length mayhave a blue color. Other colors may be used as desired.

Each bone fastener provided in an instrumentation set may havesubstantially the same thread profile and thread pitch. In oneembodiment, the thread may have about a 4 mm major diameter and about a2.5 mm minor diameter with a cancellous thread profile. In certainembodiments, the minor diameter of the thread may be in a range fromabout 1.5 mm to about 4 mm or larger. In certain embodiments, the majordiameter of the thread may be in a range from about 3.5 mm to about 6.5mm or larger. Bone fasteners with other thread dimensions and/or threadprofiles may also be used. A thread profile of the bone fasteners mayallow bone purchase to be maximized when the bone fastener is positionedin vertebral bone.

FIG. 3 depicts one embodiment of bone fastener 108. Bone fastener 108may include shank 116, head 118, and neck 120. Shank 116 may includethreading 122. In some embodiments, threading 122 may includeself-tapping start 124. Self-tapping start 124 may facilitate insertionof bone fastener 108 into vertebral bone.

Head 118 of bone fastener 108 may include various configurations toengage a driver that inserts bone fastener 108 into a vertebra. In someembodiments, the driver may also be used to remove an installed bonefastener 108 from a vertebra. In some embodiments, head 118 may includeone or more tool portions 126. Tool portions 126 may be recesses and/orprotrusions designed to engage a portion of the driver. In someembodiments, bone fastener 108 may be cannulated for use in a minimallyinvasive procedure,

Head 118 of bone fastener 108 may include one or more splines 128, asdepicted in FIG. 3. In some head embodiments, head 118 may include threesplines. Splines 128 may be equally spaced circumferentially around head118 of bone fastener 108. In some head embodiments, splines 128 may bespaced at unequal distances circumferentially around head 118. Splines128 may include various surface configurations and/or texturing toenhance coupling of bone fastener 108 with a ring of bone fastenerassembly 102. In some embodiments, sides of splines 128 may be taperedso that splines 128 form a dovetail connection with a ring. In someembodiments, spline width may be tapered so that a good interferenceconnection is established when the bone screw is coupled to a ring.Splines 128 may include one or more projections 130 to facilitatecoupling bone fastener 108 with an inner surface of a ring. In someembodiments, projections 130 may be positioned on a lower portion ofsplines 128. In some embodiments, splines 128 may include recessedsurfaces that accept projections extending from surfaces of ring 110.

Neck 120 of bone fastener 108 may have a smaller diameter than adjacentportions of head 118 and shank 116. The diameter of neck 120 may fix themaximum angle that collar 112 of bone fastener assembly 102 can berotated relative to bone fastener 108. In some embodiments, neck 120 maybe sized to allow up to about 40 degrees or more of angulation of collar112 relative to bone fastener 108. In some embodiments, neck 120 may besized to allow up to about 30 degrees of angulation of collar 112relative to bone fastener 108. In some embodiments, neck 120 may besized to allow up to about 20 degrees of angulation of collar 112relative to bone fastener 108.

FIGS. 4A and 4B depict perspective views of embodiments of ring 110.Outer surface 132 of ring 110 may have a contour that substantiallycomplements a contour of an inner surface of collar 112 in which ring110 resides. A contour of outer surface 132 of ring 110 may be aspherical portion. When ring 110 is positioned in collar 112, thecomplementary shape of outer surface 132 of ring 110 and the innersurface of collar 112 that contacts ring 110 allows angulation of collar112 relative to bone fastener 108 coupled to ring 110. The contour ofouter surface 132 of ring 110 and the inner surface of collar 112 mayinhibit removal of ring 110 from collar 112 after insertion of ring 110into collar 112.

Outer surface 132 of ring 110 may have a smooth finish. In someembodiments, outer surface 132 may be surface treated or includecoatings and/or coverings. Surface treatments, coatings, and/orcoverings may be used to adjust frictional and/or wear properties ofouter surface 132 of ring 110. In some embodiments, a portion of outersurface 132 of ring 110 may be shaped and/or textured to limit a rangeof motion of collar 112 relative to bone fastener 108 of bone fastenerassembly 102.

An inner surface of ring 110 may include one or more grooves 134 and/orone or more seats 136. Seats 136 may be circumferentially offset fromgrooves 134. Grooves 134 may be sized to allow passage of splines of abone fastener (e.g., splines 128 shown in FIG. 3) through ring 110. Whensplines 128 are inserted through grooves 134, bone fastener 108 may berotated until splines 128 align with seats 136. Bone fastener 108 may bepulled or driven so that splines 128 may be positioned in seats 136. Insome embodiments, projections (e.g., projections 130 in FIG. 3) may passover ridges 138 of ring 110. Passage of the projections over ridges 138may securely couple the bone fastener to ring 110 and inhibit separationof ring 110 from bone fastener 108.

In one embodiment, a number of grooves 134 and a number of seats 136 mayequal a number of splines 128 on a head of bone fastener 108. Seats 136and grooves 134 may be equally spaced circumferentially around the innersurface of ring 110. In some embodiments, seats 136 may becircumferentially offset about 60 degrees from grooves 134.

In some embodiments, as shown in FIG. 4A, ring 110 may be a completering without a split or slots. In some embodiments, ring 110 may includea split or slots to facilitate insertion of ring 110 into collar 112.FIG. 4B depicts one embodiment of ring 110 with a split. In someembodiments, ring 110 with a split and/or slots may be compressed toease insertion into collar 112. Once positioned in collar 112, ring 110may expand to its original uncompressed dimensions, thus inhibitingremoval from collar 112.

As used herein, the term “collar” includes any element that wholly orpartially encloses or receives one or more other elements. A collar mayenclose or receive elements including, but not limited to, a bonefastener, closure member 106, a ring, and/or an elongated member. Insome embodiments, a collar may couple two or more other elementstogether (e.g., an elongated member and a bone fastener). A collar mayhave any of various physical forms. In some embodiments, a collar mayhave a “U” shape, however it is to be understood that a collar may alsohave other shapes.

A collar may be open or closed. A collar having a slot and an open topsuch as collar 112 shown in FIG. 2 may be referred to as an “opencollar.” A bone fastener assembly that includes an open collar may bereferred to as an “open fastener.” In some embodiments, elongated member104 may be top loaded into the open fastener. Closure member 106 may becoupled to collar 112 to secure elongated member 104 to the openfastener.

A collar that does not include a slot and an open top may be referred toas a “closed collar.” A spinal implant that includes a closed collar maybe referred to as a “closed implant.” A closed collar may include anaperture, bore, or other feature in side surfaces for accommodatingother components of a stabilization system (e.g., an elongated member).A setscrew may be used to securely couple elongated member 104 to aclosed implant.

Collar 112 may include body 140 and arms 142. Arms 142 may extend frombody 140. Body 140 of collar 112 may be greater in width than a widthacross arms 142 of collar 112 (i.e., body 140 may have a maximumeffective outer diameter greater than a maximum effective outer diameterof arms 142). A reduced width across arms 142 may allow a detachablemember to be coupled to the arms without substantially increasing amaximum effective outer diameter along a length of collar 112. Thus, areduced width across arms 142 may reduce bulk at a surgical site.

A height of body 140 may range from about 3 millimeters (mm) to about 7mm. In one embodiment, a height of body 140 is about 5 mm. Body 140 mayinclude opening 144 in a lower surface of the body. To inhibit passageof ring 110 from collar 112, opening 144 may be smaller than an outerdiameter of ring 110. Inner surface 146 may be machined to complement aportion of an outer surface of ring 110 that is to be positioned incollar 112. Machining of inner surface 146 may enhance retention of ring110 in collar 112. Inner surface 146 of body 140 may be complementary inshape to a portion of outer surface 132 of ring 110 (see FIG. 4) so thatring 110 is able to swivel in collar 112. Inner surfaces and/or outersurfaces of collar 112 may be surface treated or include coatings and/orcoverings to modify frictional properties or other properties of collar112.

Inner surfaces 146 of arms 142 may include modified thread 148. Modifiedthreads 148 may engage complementary modified threads of closure member106 to secure elongated member 104 to a bone fastener assembly. Modifiedthreads 148 may have a constant pitch or a variable pitch.

A height and a width of arms 142 may vary. Arms 142 may range in heightfrom about 8 mm to about 15 mm. In one embodiment, a height of arms 142is about 11 mm. A width (i.e., effective diameter) of arms 142 may rangefrom about 5 mm to 14 mm. Arms 142 and body 140 may form slot 150. Slot150 may be sized to receive elongated member 104. Slot 150 may include,but is not limited to, an elongated opening of constant width, anelongated opening of variable width, a rectangular opening, atrapezoidal opening, a circular opening, a square opening, an ovoidopening, an egg-shaped opening, a tapered opening, and combinationsand/or portions thereof. In some embodiments, a first portion of slot150 may have different dimensions than a second portion of slot 150. Incertain embodiments, a portion of slot 150 in first arm 142 may havedifferent dimensions than a portion of slot 150 in second arm 142. Whenelongated member 104 is positioned in slot 150, a portion of elongatedmember 104 may contact a head of bone fastener 108 positioned in collar112.

In one embodiment, arms 142 of collar 112 may include one or moreopenings and/or indentions 152. Indentions 152 may vary in size andshape (e.g., circular, triangular, rectangular). Indentions 152 may beposition markers and/or force application regions for instruments thatperform reduction, compression, or distraction of adjacent vertebrae. Insome embodiments, openings and/or indentions may be positioned in thebody of collar 112.

Arms 142 may include ridges or flanges 154. Flange 154 may allow collar112 to be coupled to a detachable member so that translational motion ofcollar 112 relative to the detachable member is inhibited. Flanges 154may also include notches 156. A movable member of a detachable membermay extend into notch 156. When the movable member is positioned innotch 156, a channel in the detachable member may align with a slot incollar 112. With the movable member positioned in notch 156, rotationalmovement of collar 112 relative to the detachable member may beinhibited.

FIG. 6 depicts a cross-sectional representation of bone fastener 108,ring 110, and collar 112 of bone fastener assembly 102. Bone fastener108 of bone fastener assembly 102 may include passage 114. Bone fastener108 may be cannulated (i.e., passage 114 may run through the full lengthof the bone fastener). A guide wire may be placed through passage 114 sothat bone fastener 108 may be inserted into a vertebra at a desiredlocation and in a desired angular orientation relative to the vertebrawith limited or no visibility of the vertebra

In some embodiments, bone fastener assembly 102 may be a fixed anglefastener. FIG. 7 depicts one embodiment of fixed angle bone fastener103. Collar 112 and bone fastener 108 may be formed as a unitary pieceof metal. A fixed angle bone fastener assembly 102 may be positioned asthe first bone fastener assembly 102 inserted into a vertebra.

FIGS. 8A-8C depict views of collar 112 and ring 110 during top loadinginsertion of ring 110 into collar 112. Ring 110 may be positioned asshown in FIG. 8A and inserted past arms 142 into body 140. FIG. 8Bdepicts a cross-sectional view of ring 110 and collar 112 afterinsertion of ring 110 into collar 112 through slot 150. After insertionof ring 110 into collar 112, ring 110 maybe rotated so that bonefastener 108 may be positioned through ring 110. FIG. 8C depicts across-sectional view of ring 110 and collar 112 after rotation of ring110 in collar 112.

FIGS. 9A-9C depict views of collar 112 and ring 110 during bottomloading insertion of ring 110 into collar 112. Ring 110 may bepositioned as shown in FIG. 9A and inserted into body 140 through anopening in the bottom of collar 112. In some embodiments, ring 110 maybe inserted into body 140 through a groove or a slot in the bottom ofcollar 112. In certain embodiments, collar 112 designed for bottominsertion of ring 110 may have narrower slot 150 than collar 112designed for top insertion of ring 110. Collar 112 with narrower slot150 may allow elongated member 104 with a reduced diameter to be used ina spinal stabilization system. Collar 112 with narrower slot 150 may beused to reduce bulk at a surgical site. FIG. 9B depicts across-sectional view of ring 110 and collar 112 after insertion of ring110 into collar 112 through the opening in the bottom of collar 112.After insertion of ring 110 into collar 112, ring 110 may be rotated sothat bone fastener 108 may be positioned through ring 110. Tolerancebetween an outer surface of ring 110 and an inner surface of body 140shown in FIGS. 8A-8C and 9A-9C may require force to be applied to thering to drive the ring into the body. Once ring 110 is positioned inbody 140, the ring may expand slightly. In certain embodiments,significant force may be required to remove ring 110 from body 140(i.e., the ring may be substantially unreleasable from the body). Therequired force may inhibit unintentional removal of ring 110 from body140. FIG. 9C depicts a cross-sectional view of ring 110 and collar 112after rotation of the ring in collar 112,

FIG. 10A depicts bone fastener 108 before insertion of the bone fastenerinto ring 110 positioned in collar 112. Splines 128 may be aligned withgrooves 134 to allow passage of head 118 through ring 110 and intocollar 112. FIG. 10B depicts bone fastener 108, ring 110, and collar 112after bone fastener 108 has been rotated and head 118 has been coupledto seats in ring 110to form bone fastener assembly 102. Inserting bonefastener 108 through opening 144 in collar 112 (depicted in FIG. 10A)may allow use of bone fasteners that have shanks and/or heads withlarger diameters than can pass through slot 150. Bone fasteners 108 withlarge diameter shanks may form bone fastener assembly 102 (threaded orotherwise) that securely fastens to vertebral bone during use.

Bone fastener 108 may be rotatably positioned in collar 112 such thatbone fastener 108 is able to move radially and/or rotationally relativeto collar 112 (or collar 112 relative to bone fastener 108) within adefined range of motion. The range of motion may be provided within aplane, such as by a hinged connection, or within a three-dimensionalregion, such as by a ball and socket connection. Motion of bone fastener108 relative to collar 112 (or collar 112 relative to bone fastener 108)may be referred to as “angulation” and/or “polyaxial movement”. FIG. 11depicts bone fastener assembly 102 with central axis 158 of collar 112aligned with central axis 160 of bone fastener 108. Bone fastener 108may be angulated in a symmetrical conical range of motion characterizedby angle at about the aligned axes. Bone fastener 108 may be constrainedfrom motion outside of limit axis 162 by contact between neck 120 ofbone fastener 108 and collar 112. Alignment of axis 160 of bone fastener108 with central axis 158 of collar 112 may be considered a neutralposition relative to the range of motion. The alignment is a neutralposition because bone fastener 108 may be angulated an equal amount inany direction from central axis 158. When a driver is inserted into bonefastener 108, axis 160 of bone fastener 108 may be substantially alignedwith axis 158 of collar 112 to facilitate insertion of the bone fastenerinto a vertebral body.

In sortie embodiments, a range of motion of collar 112 may be skewedfrom a full conical range of motion relative to aligned central axes ofcollar 112 and bone fastener 108 coupled to collar 112. In someembodiments, a distal end of collar 112 may be shaped to skew, or bias,the range of motion from the range of motion depicted in FIG. 11. FIGS.12A and 12B depict bone fastener assemblies 102 with biased collars 112.Body 140 of biased collar 112 may be shaped to restrict relativemovement of bone fastener 108 (and/or collar 112) to a skewed conicalrange of motion defined by limit axes 162. As depicted by limit axes 162in FIG. 12A, a first arm 142 of collar 112 may approach bone fastener108 more closely than a second arm of collar 112. As suggested by limitaxes 162 in FIG. 12B, a first opening of the slot between arms 142 ofcollar 112 may approach bone fastener 108 more closely than a secondopening of the slot.

Other biased collars 112 may be designed to selectively restrictrelative movement of collars 112 and/or bone fasteners 108. In someembodiments, biased collar 112 may be attached to a detachable membersuch that a surgeon performing a minimally invasive procedure mayselectively align the portion of collar 112 with the greater range ofmotion as needed. For example, collar 112 depicted in FIG. 12B may becoupled to a single-level (e.g., C-shaped) sleeve so that the side ofcollar 112 (i.e., the side of the slot) with a larger range of motion ispositioned next to a channel opening of sleeve 244.

When biased collars 112 of bone fastener assemblies 102 are coupled to adetachable member and a drive mechanism is coupled to bone fastener 108of bone fastener assembly 103, central axis 158 of collar 112 may alignwith central axis 160 of bone fastener 108 to facilitate insertion ofbone fastener 108 into bone. In some embodiments, the bias of collar 112may be so large that a flexible drive member is needed to drive bonefastener 108 into bone.

In some embodiments, one or more biased collars 112 may be used in aspinal stabilization system. The spinal stabilization systems may besingle-level systems or multi-level systems. Biased collars 112 may beused to accommodate the increasing angle of the pedicle corridor foreach lumbar vertebra. The angle may increase by about 5 degrees for eachsuccessive lumbar vertebra. FIGS. 13A and 13B depict superior andposterior views of one embodiment of a spinal stabilization systemincluding bone fastener assembly 102A coupled to pedicle 164A andvertebra 166A and bone fastener assembly 102B coupled to pedicle 164Band vertebra 166B.

In some embodiments, bone fastener 108 of bone fastener assembly 102Amay engage pedicle 164A at pedicle angle φA (phi-Alpha) relative tosagittal plane 168. Pedicle angle φA (phi-Alpha) may range between about13 degrees and about 17 degrees. In some embodiments, collar 112A ofbone fastener assembly 102A may be unbiased. Pedicle angle φβ (phi-Beta)may range between about 18 degrees and about 22 degrees. In someembodiments, collar 112B may have a bias angle β (Beta) of about 5degrees. In some embodiments, bone fastener assembly 102B may engagepedicle 164B at pedicle angle φβ (phi-Beta). Because the bias of collar112E is approximately equal to the difference between the pedicle anglesof the two vertebrae, slots 150A and 150B in bone fastener assemblies102A and 102B, respectively, may be generally aligned when both bonefasteners 108 are in neutral positions.

Angulation of either or both collars 112 of bone fastener assemblies102A and 102B may allow fine adjustment of engagement angles of bonefastener assemblies 102A and 102B. In addition, collar angulation mayallow adjustment in the orientation of bone fasteners 108 in a sagittalplane (i.e., to conform to lordosis of a spine) while still allowingcollars 112 to be easily coupled with elongated member 104. Elongatedmember 104 may be disposed in slots 150A and 150B and secured by closuremembers 106. In some embodiments, a flexible driver or a polyaxialdriver (e.g., a driver with a universal joint) may be used to drive theheads of bone fasteners 108 from a position that is off-axis from bonefasteners 108 to reduce the size of an opening of the body needed toimplant the spinal stabilization system.

Closure member 106 may be coupled to collar 112 of bone fastenerassembly 102 to couple elongated member 104 positioned in collar 112 tobone fastener assembly 102. In some embodiments, closure member 106 maybe cannulated. In certain embodiments, closure member 106 may have asolid central core. Closure member 106 with a solid central core mayallow more contact area between closure member 106 and a driver used tocouple closure member 106 to collar 112. Closure member 106 with a solidcentral core may provide a more secure connection to elongated member104 than a cannulated closure member 106 by providing contact againstelongated member 104 at a central portion of closure member 106 as wellas near an edge of closure member 106.

FIG. 1 depicts closure members 106 coupled to bone fastener assemblies102. FIG. 14 depicts closure member 106 prior to insertion of closuremember 106 into collar 112 of bone fastener assembly 102. Closure member106 may include tool portion 170 and male modified thread 172. Toolportion 170 may couple to a tool that allows closure member 106 to bepositioned in collar 112. Tool portion 170 may include variousconfigurations (e.g., threads, hexalobular connections, hexes) forengaging a tool (e.g., a driver). Male modified thread 172 may have ashape that complements the shape of a female modified thread in arms ofcollar 112 (e.g., modified thread 148 depicted in FIG. 5).

FIG. 15 depicts a cross-sectional representation of closure member 106taken substantially along plane 15-15 of FIG. 14. Closure member 106 mayinclude removal openings 174. A drive tool may be inserted into removalopenings 174 to allow removal of closure member 106 after tool portion170 has been sheared off. Removal openings 174 may include any of avariety of features including, but not limited to, sockets, holes,slots, and/or combinations thereof. In one embodiment, removal openings174 are holes that pass through bottom surface 176 of closure member106.

A bottom surface of closure member 106 may include structure and/ortexturing that promotes contact between closure member 106 and elongatedmember 104. A portion of the structure and/or texturing may enter and/ordeform elongated member 104 when closure member 106 is coupled toelongated member 104. Having a portion of closure member 106 enterand/or deform elongated member 104 may couple elongated member 104 toclosure member 106 and bone fastener assembly 102 so that movement ofelongated member 104 relative to bone fastener assembly 102 isinhibited. In one embodiment, such as the embodiment depicted in FIG.15, bottom surface 176 of closure member 106 may include point 178 andrim 180. In some embodiments, rim 180 may come to a sharp point. In someembodiments, a height of rim 180 may be less than a height of point 178.In some embodiments, a height of rim 180 may be the same or larger thana height of point 178. In some embodiments, rim 180 may not extendcompletely around closure member 106. For example, eight or moreportions of rim 180 may be equally spaced circumferentially aroundclosure member 106. In certain embodiments, a solid central coreincluding point 178 and rim 180 may enhance the ability of closuremember 106 to secure elongated member 104 in collar 112.

FIG. 16 depicts a portion of a spinal stabilization system with closuremember 106 coupled to collar 112 before tool portion 170 is sheared off.Closure member 106 may couple to collar 112 by a variety of systemsincluding, but not limited to, standard threads, modified threads,reverse angle threads, buttress threads, or helical flanges. A buttressthread on closure member 106 may include a rearward-facing surface thatis substantially perpendicular to the axis of the closure member.Closure member 106 may be advanced into an opening in collar 112 toengage a portion of elongated member 104. In some embodiments, closuremember 106 may inhibit movement of elongated member 104 relative tocollar 112.

FIG. 17A depicts a cross-sectional view of closure member 106 coupled tobone fastener assembly 102. Closure member 106 may include male modifiedthread 172. Male modified thread 172 may include male distal surface 182and male proximal surface 184, as shown in FIG. 17B. Collar 112 mayinclude female modified thread 148 on an inside surface of arms 142.Female modified thread 148 may include female proximal surface 186 andfemale distal surface 188. Male proximal surface 184 may couple tofemale distal surface 188 during use. Male proximal surface 184 andfemale distal surface 188 may be load-bearing surfaces. A load mayresult from an upward load on closure member 106, such as a loadresulting when elongated member 104 positioned in a slot of collar 112is secured to bone fastener assembly 102 by closure member 106.

Raised portions 190 and recessed portions 192 may be included on maledistal surface 182 and female proximal surface 186. Cooperating surfaces194 of modified threads 172 and 148 may contact or be proximate to oneanother during use. As used herein, “proximate” means near to or closerto one portion of a component than another portion of a component.Engagement of cooperating surfaces 194 of modified threads 172 and 148during use may inhibit radial expansion of collar 112. Engagement ofcooperating surfaces 194 may inhibit spreading of arms 142 away fromeach other (i.e., inhibit separation of the arms). In some embodiments,cooperating surfaces 194 may be substantially parallel to a central axisof closure member 106. In some embodiments, cooperating surfaces 194 maybe angled relative to a central axis of closure member 106.

In some embodiments, a proximal surface of a male modified thread mayinclude raised and recessed portions. FIG. 18A depicts a cross-sectionalview of bone fastener assembly 102 coupled to closure member 106 withraised and recessed portions on a proximal surface of male modifiedthread 172. FIG. 18B depicts a cross-sectional view of raised portions190 at male proximal surface 184 of male modified thread 172 and femaledistal surface 188 of female modified thread 148. Male proximal surface184 may include an overall positive slope S such that point A near thetop of male modified thread 172 is distal from point B at the base ofthe male modified thread. Alternatively, male proximal surface 184 mayinclude an overall negative slope or a slope of about zero.

In one embodiment, bone fastener assembly 102 and closure member 106 maybe coupled with a running fit. A running fit (i.e., a fit in which partsare free to rotate) may result in predictable loading characteristics ofa coupling of bone fastener assembly 102 and closure member 106.Predictable loading characteristics may facilitate use of closure member106 with a break-off portion designed to shear off at a predeterminedtorque. A running fit may also facilitate removal and replacement ofclosure members 106. In some embodiments, closure member 106 may includean interference fit (e.g., crest-to-root radial interference).

In one embodiment, a position (i.e., axial position and angularorientation) of a modified thread of collar 112 may be controlled, or“timed,” relative to selected surfaces of collar 112. For example, amodified thread form may be controlled relative to a top surface ofcollar 112 and an angular orientation of the slots of collar 112. Insome embodiments, positions of engaging structural elements of othercoupling systems (e.g., thread forms) may be controlled.

Controlling a position of a modified thread form may affect a thicknessof a top modified thread portion of collar 112. In FIG. 5, top modifiedthread portion 196 is the first modified thread portion to engageclosure member 106. In one embodiment, a position of a modified threadform may be selected such that the thickness of the leading edge of atop modified thread portion is substantially equal to the full thicknessof the rest of the modified thread.

Controlling a position of a modified thread form of collar 112 mayincrease a combined strength of engaged modified thread portions forcollar 112 of a given size (e.g., wall height, modified threaddimensions, and thread pitch). Controlling a position of the modifiedthread form may reduce a probability of failure of modified threadportions, and thus reduce a probability of coupling failure betweencollar 112 and closure member 106. Controlling the position of amodified thread form in collar 112 of bone fastener assembly 102 mayincrease a combined strength of engaged collar and closure membermodified thread portions such that failure of the modified threadportions does not occur prior to the intended shearing off of a toolportion of the closure member. For example, a tool portion of closuremember 106 may be designed to shear off at about 90 in-lbs of torque,while the combined modified thread portions may be designed to withstanda torque on closure member 106 of at least 120 in-lbs.

If a thickness of a modified thread portion of a given size and profileis reduced below a minimum thickness, the modified thread portion maynot significantly contribute to the holding strength of the modifiedthread of collar 112. In one embodiment, a position of a modified threadform of collar 112 may be controlled such that a thickness of a topmodified thread portion is sufficient for the portion to increase aholding strength of collar 112. In one embodiment, a top modified threadportion may have a leading edge thickness of about 0.2 mm.

In one embodiment, a position of a modified thread form of collar 112may be selected to ensure that closure member 106 engages a selectedminimum number of modified thread portions on each arm of collar 112. Inone embodiment, at least two modified thread portions having a fullthickness over width w of arm 142 of collar 112 (shown in FIG. 5) may beengaged by closure member 106 at each arm. Alternatively, closure member106 may engage parts of three or more modified thread portions on eacharm, with the total width of the portions equal to at least twofull-width portions. Allowances may be made for tolerances in thecomponents (e.g., diameter of the elongated member) and/or anticipatedmisalignment between the components, such as misalignment betweenelongated member 104 and a slot. In one embodiment, a substantiallyequal number of modified thread portions in each arm may engage closuremember 106 when elongated member 104 is coupled to bone fastenerassembly 102.

Various instruments may be used in a minimally invasive procedure toform a spinal stabilization system in a patient. The instruments mayinclude, but are not limited to, positioning needles, guide wires,dilators, bone awls, bone taps, sleeves, drivers, tissue wedges,elongated member length estimating tools, mallets, tissue retractors,positioning tools and tissue dilators. The instruments may be providedin an instrumentation set. The instrumentation set may also includecomponents of the spinal stabilization system. The components of thespinal stabilization system may include, but are not limited to, bonefastener assemblies of various sizes and/or lengths, elongated members,and closure members.

Instruments used to install a spinal stabilization system may be made ofmaterials including, but not limited to, stainless steel, titanium,titanium alloys, ceramics, and/or polymers. Some instruments may beautoclaved and/or chemically sterilized. Some instruments may includecomponents that cannot be autoclaved or chemically sterilized.Components of instruments that cannot be autoclaved or chemicallysterilized may be made of sterile materials. The sterile materials maybe placed in working relation to other parts of the instrument that havebeen sterilized.

A targeting needle may be used to locate an entry point in a vertebralbody for bone fastener 108 of bone fastener assembly 102. In someembodiments, the targeting needle may be a Jarnshid® bone marrow biopsyneedle. FIG. 19 depicts one embodiment of targeting needy; 198.Targeting needle 198 may include outer housing 200 and member 202. FIG.20 depicts one embodiment of outer housing 200. Outer housing 200 mayinclude hollow shaft 204 and handle 206. Scale markings 208 may beprinted, etched, or otherwise placed on hollow shaft 204. Scale markings208 may be used to approximate a length of bone fastener 108 needed fora vertebra. Handle 206 may provide a grip that allows a user tomanipulate the targeting needle. Handle 206 may include threaded portion210. Threaded portion 210 may couple to threading on a portion of atargeting needle member to secure the member to outer housing 200.

FIG. 21 depicts one embodiment of member 202 of a targeting needle.Member 202 may include point 212 and cap 214. Point 212 may be placedthrough a hollow shaft of an outer housing of the targeting needle. Cap214 may include threading 216. Member 202 may be rotated relative to theouter housing to couple threading 216 with threading in a handle of theouter housing. In some embodiments, the member may be coupled to theouter housing by another type of connection system (e.g., by placementof a key in a keyway). With member 202 positioned in an outer housing,point 212 may extend from a distal end of a hollow shaft of the outerhousing. Cap 214 may be used as an impact surface for driving thetargeting needle in bone.

FIG. 22 and FIG. 23 depict embodiments of guide wire 218. In someembodiments, guide wire 218 may be an 18-gauge K-wire. In someembodiments, guide wire 218 may pass down a shaft of a targeting needleouter housing. In some embodiments, guide wire 218 may be from about 15cm to about 65 cm in length. In some embodiments, guide wires 218provided in an instrumentation set are about 46 cm in length. In someembodiments, the length of guide wire 218 may allow a surgeon and/orassistants to hold at least one portion of the guide wire at all timeswhen the guide wire is inserted into vertebral bone, even duringinsertion, use, and removal of instruments along a length of guide wire218. In some embodiments, guide wire 218 that can be held continuouslyduring a surgical procedure may inhibit removal or advancement of theguide wire from a desired position during a minimally invasive surgicalprocedure.

In some embodiments, a distal end of guide wire 218 may include point220. Point 220 may facilitate insertion of the distal end of guide wire218 into vertebral bone. As depicted in FIG. 23, a distal end of guidewire 218 may not be pointed. A position of an unpointed guide wire inbone may be easier to maintain during a spinal stabilization procedure.

In some embodiments, guide wire 218 may be Inserted in an incision andadvanced into the body near elongated member 104. In some embodiments,guide wire 218 may be inserted in an incision and advanced into the bodyunder elongated member 104. In some embodiments, guide wire 218 may beinserted in an incision and advanced into the body over elongated member104. In some embodiments, guide wire 218 may be inserted in an incisionand advanced into the body under elongated member 104 on one side of thespine and over elongated member 104 positioned on the other side of thespine. In some embodiments, guide wire 218 may have a solidcross-section and advance as a single unit. In some embodiments, guidewire 218 may have two or more portions such that one or more portions ofguide wire 218 may be advanced independent of other portions of guidewire 218.

Dilators may be used during a minimally invasive surgical procedure topush aside tissue and create space to access vertebral bone. In someembodiments, four tissue dilators of increasing diameter may be used toestablish sufficient working space to accommodate instruments and spinalstabilization system components. In some embodiments, especially for amid-vertebra or for mid-vertebrae of a multi-level stabilization system,only three dilators may be needed to form sufficient working space.Dilators in an instrumentation set may increase in diameterincrementally by a selected amount. For example, outside diameters ofdilators in an instrumentation set may increase sequentially byincrements of about 0.5 mm.

A bone awl may be used to breach cortical bone of a pedicle. FIG. 24depicts one embodiment of bone awl 222. Bone awl 222 may include handle224, passage 226, and tip 228. Handle 224 may provide a secure grip thatallows a surgeon to breach cortical bone of a pedicle with tip 228.Guide wire 218 that is inserted in vertebral bone in a desiredorientation may be inserted through passage 226 that extends throughbone awl 222. Bone awl 222 may be moved down guide wire 218 so that tip228 contacts the pedicle.

Bone awl 222 may have a length that allows guide wire 218 positioned invertebral bone to always be held in at least one location when guidewire 218 is placed through passage 226 in the needle. In someembodiments, handle 224 may be removable from a shaft of bone awl 222 sothat guide wire 218 may always be held during use of bone awl 222.

During some surgical procedures downward force and some rotation of boneawl 222 may be sufficient to breach cortical of a vertebra. During somesurgical procedures, an impact force may be needed for bone awl 222 tobreach cortical bone. In some embodiments, guide wire 218 may beremoved, bone awl 222 may be used to breach cortical bone, and guidewire 218 may be reinserted. In some embodiments, a small dilator may beplaced over the portion of guide wire 218 extending from bone awl 222 sothat a first end of the dilator contacts bone awl 222. A mallet or otherimpact device may be used against a second end of the dilator so thatbone awl 222 breaches cortical bone of the vertebra. The dilator may beremoved from bone awl 222 and contact with guide wire 218 may bereestablished.

A bone tap may be used to form a threaded passage of a desired depththrough a pedicle and into a vertebral body. FIG. 25 depicts oneembodiment of tap 230. Tap 230 may include passage 232, shaft 234,removable handle 236, flutes 238, and indicia 240. Passage 232 mayextend through a length of shaft 234 and removable handle 236. Guidewire 218 positioned in vertebral bone may be inserted into a distal endof passage 232 so that tap 230 can be moved down guide wire 218 towardthe bone.

In one embodiment of tap 230, a proximal portion of shaft 234 mayinclude at least one flat portion that fits in a mating portion ofremovable handle 236. Proximal end of shaft 234 may also include adetent depression. The flat portion may allow for rotation of shaft 234when removable handle 236 is rotated. One embodiment of removable handle236 may include spring-loaded release 242. When spring-loaded release242 is compressed (i.e., drawn upwards), a detent in removable handle236 may be movable. When spring-loaded release 242 is not compressed,movement of the detent may be inhibited. When shaft 234 is positioned inremovable handle 236, the detent of removable handle 236 may bepositioned in the detent depression of shaft 234 to couple shaft 234 toremovable handle 236.

A tap portion of tap 230 may have a known length. As shown in FIG. 25, atap portion of tap 230 may have a length t. In some embodiments, t maybe about 20 mm, about 40 mm, about 60 mm, or greater. For example, t maybe about 45 mm. X-ray monitoring of a depth of a tap portion of knownlength may allow a medical practitioner to assess a depth of a holetapped in a bone. In some embodiments, the hole may be tapped toaccommodate bone fastener 108 of a desired length. In certainembodiments, bone fastener 108 may be chosen to accommodate a holetapped to a desired depth.

Guide wire 218 positioned in vertebral bone may be held near a top of adilator inserted over guide wire 218 at a surgical site. A proximal endof guide wire 218 may be positioned through a distal end of a passage inshaft 234 of tap 230 without removable handle 236 coupled to shaft 234.A proximal portion of guide wire 218 may be held when the proximalportion of guide wire 218 extends beyond the top of shaft 234. A portionof guide wire 218 may always be held during use of tap 230. Shaft 234may be moved down guide wire 218 until shaft 234 contacts the vertebralbone. Guide wire 218 may be held near the top of shaft 234 and guidewire 218 may be positioned through passage 232 of removable handle 236.When guide wire 218 extends out of passage 232 through removable handle236, guide wire 218 may be held above removable handle 236. Handle 236may be coupled to shaft 234 using spring-loaded release 242.

A first reading of indicia 240 relative to a proximal end of a dilatormay be taken when a first flute of flutes 238 is located at a pedicle.Tap 230 may be rotated no that flutes 238 form a threaded openingthrough the pedicle and into a vertebral body. Flutes 238 may have adiameter that is about 0.1 mm to about 0.7 mm less than a maximum threadflight of bone fastener 108 to be positioned in the threaded openingformed by the flutes. In one embodiment, tap 230 may form a thread thatis about 0.5 mm less than a maximum thread flight of bone fastener 108to be positioned in the threaded opening formed by the flutes. Aposition of tap 230 may be monitored using a fluoroscope. When thethreaded opening is formed to a desired depth, a second reading ofindicia 240 relative to the dilator may be taken. A length of bonefastener 108 to be inserted into the vertebral body may be estimated bytaking the difference between the indicia readings.

After a threaded opening is formed to a desired depth, tap 230 may beremoved by rotating tap 230 until flutes 238 are disengaged fromvertebral bone. Removable handle 236 may be separated from shaft 234,and removable handle 236 may be removed with guide wire 218 always heldin at least one location. After removable handle 236 is removed fromguide wire 218, shaft 234 may be removed with guide wire 218 always heldin at least one location.

A detachable member may be used as a guide to install bone fasteners 108of bone fastener assembly 102 in vertebral bone. A detachable member maybe coupled to collar 112 of bone fastener assembly 102. A distal end ofa detachable member may be tapered or angled to reduce bulk at asurgical site. Instruments may be inserted into the detachable member tomanipulate bone fastener assembly 102. Movement of the detachable membermay alter an orientation of collar 112 relative to bone fastener 108 ofbone fastener assembly 102. In some embodiments, a detachable member maybe used as a retractor during a spinal stabilization procedure.

A detachable member for a single-level vertebral stabilization systemmay include one or more channels in a wall of the detachable member toallow access to an adjacent vertebra. For some single-level vertebralstabilization procedures, only single-channel detachable members (i.e.,detachable members with a single channel in a wall of the detachablemember) may be used. For other single-level vertebral stabilizationprocedures, one or more multi-channel detachable members (i.e.,detachable members with two or more channels in a wall of the detachablemember) may be used. Channels may provide flexibility to or enhanceflexibility of a multi-channel detachable member. In some embodiments, aproximal portion of a multi-channel detachable member may have a solidcircumference. A region of solid circumference in a multi-channeldetachable member may enhance stability of the multi-channel detachablemember. In some embodiments, a multi-channel detachable member may belonger than a single-channel detachable member.

A detachable member used at a middle vertebra in a multi-levelstabilization procedure may be a multi-channel detachable member.Channels in a multi-channel detachable member may allow access toadjacent vertebrae from a middle vertebra. A detachable member used atan end vertebra of a multi-level stabilization system may be asingle-channel detachable member or a multi-channel detachable member. Asystem for coupling bone fastener assembly 102 to a multi-channeldetachable member may include a limiter that inhibits spreading of armsof the detachable member to inhibit release of bone fastener assembly102 from the detachable member.

A channel in a wall of a detachable member may allow access to avertebra that is to be stabilized with a spinal stabilization systembeing formed. In some embodiments, a single-channel detachable membermay be coupled to bone fastener assembly 102 to be inserted intovertebral bone of a first vertebra. The single-channel detachable membermay allow access to a second vertebra from the first vertebra. In someembodiments, a multi-channel detachable member may be coupled to bonefastener assembly 102 to be inserted into vertebral bone of a firstvertebra. The multi-channel detachable member may allow access from thefirst vertebra to adjacent vertebrae.

Instruments may access bone fastener assembly 102 through a passage in adetachable member. In some embodiments, a channel in a wall of adetachable member may extend a full length of the detachable member. Insome embodiments, especially in embodiments of multi-channel detachablemembers, a channel in a wall of a detachable member may extend only aportion of the length of the detachable member. In some embodiments, achannel in a wall of a detachable member may extend 25%, 50%, 75%, 80%,90%, 95% or more of the length of the detachable member, A channel mayextend to a distal end of a detachable member such that elongated member104 inserted in the channel may pass from the detachable member into aslot of collar 112 of bone fastener assembly 102 coupled to thedetachable member.

A channel in a detachable member may be any of a variety of shapes. Achannel may have a width that exceeds a width (e.g., a diameter) ofelongated member 104 that is to be inserted in the channel. In someembodiments, a channel may be a linear opening parallel to alongitudinal axis of the detachable member. In some embodiments, achannel may have a non-linear shape including, but not limited to, ahelical pattern, an arc, an “L” shape, or an “S” shape. A non-linearchannel may allow elongated member 104 to travel along a predeterminedpath. In certain embodiments, adjacent detachable members may includechannels with matching profiles, allowing ends of elongated member 104to follow similar paths down the detachable member channels.

Movable members may extend through portions of a detachable memberproximate a channel in the detachable member. Movable members may engagenotches in collar 112 to establish a radial orientation of thedetachable member on collar 112 and/or to inhibit rotation of collar 112relative to the detachable member. A distal end of a movable member maybe flat, curved, or angled. In some embodiments, a distal end of amovable member may be threaded. In some embodiments, a distal end of amovable member may be a projection that engages an opening in collar112. In some embodiments, an upper surface of collar 112 and/or asurface of a distal end of a movable member may be textured to inhibitrotation of collar 112 relative to the detachable member. In certainembodiments, a proximal end of a movable member may include a toolengaging portion. A tool engaging portion may include, but is notlimited to, a hex section, a hexalobular section, a tapered section, abead, a knot, a keyed opening, a coating, a threading, and/or aroughened surface for engaging a drive that rotates or otherwisedisplaces the movable member.

A cross section transverse to a longitudinal axis of a detachable membermay have shapes including, but not limited to, circular, ovoid, square,pentagonal, hexagonal, and combinations thereof. In some embodiments, adetachable member may be hollow. In certain embodiments, a thickness ofa hollow detachable member may be uniform. In certain embodiments, athickness of a hollow detachable member may vary along the length of thedetachable member. A detachable member with a passage extendinglongitudinally from a first end of the detachable member to a second endof the detachable member may be referred to as a “sleeve”.

FIG. 26 depicts one embodiment of sleeve 244. Sleeve 244 may be amulti-channel sleeve.

Sleeve 244 may include wall 246, channels 248, passage 250, movablemembers 252, and flange 254. Channels 248 may extend from a distal endof sleeve 244 through a portion of wall 246. Channels 248 may allowinstruments to be positioned and used to form a plane through softtissue to one or more adjacent vertebrae. Elongated member 104 may beinserted in the tissue plane and positioned in collars 112 of bonefastener assemblies 102 anchored in vertebrae and coupled to sleeves244. Passage 250 may allow instruments to be positioned and used tomanipulate bone fastener assembly 102 that is coupled to a distal end ofsleeve 244. Movable members 252 may be part of a system that couplesbone fastener assembly 102 to sleeve 244. In some embodiments, movablemembers 252 may include tool engaging portion 256. A driver may bepositioned in tool portion 256. The driver (e.g., a hex wrench) may beused to extend or retract a distal end of movable member 252. A distalend of sleeve 244 may include flange 254 that mates with a complementaryflange on collar 112 of bone fastener assembly 102. A distal end ofsleeve 244 may be tapered to reduce bulk (e.g., reduce spin diameter) ata surgical site.

FIG. 27 depicts a top view of one embodiment of sleeve 244 coupled tobone fastener assembly 102. Tool portion 126 of bone fastener 108 is ahexalobular connection.

FIG. 28 depicts a cross-sectional representation of a portion of sleeve244 with bone fastener assembly 102 taken substantially along line 28-28of FIG. 27. Flange 254 of sleeve 244 may mate with flange 154 of collar112 to inhibit translation of sleeve 244 relative to collar 112. Sleeve244 may also include stop 258. Stop 258 may engage a portion of collar112 to inhibit separation of walls 246. During use, stop 258 may inhibitundesired separation of bone fastener assembly 102 from sleeve 244.

FIG. 29 depicts a cross-sectional representation of a portion of sleeve244 with bone fastener assembly 102 and elongated member 104 takensubstantially along line 29-29 of FIG. 27. Distal ends of movablemembers 252 may extend into notches (e.g., notches 156 depicted in FIG.5) in collar 112. Portions of walls 246 of sleeve 244 may includethreads. Portions of movable members 252 may include threadscomplementary to threaded portions of walls 246. Threading of movablemembers 252 may engage threading in walls 246 such that rotation ofmovable members 252 advances or retracts movable members 252 relative towalls 246.

As shown in FIG. 29, collar 112 may be designed such that elongatedmember 104 lies below a distal end of sleeve 244. Coupling sleeve 244 tocollar 112 above elongated member 104 may reduce bulk at a surgicalsite. With elongated member 104 coupled to collar 112 below a distal endof sleeve 244, sleeve 244 may be removed without interference fromelongated member 104 of a spinal stabilization system.

FIG. 30 depicts one embodiment of sleeve 244. Sleeve 244 may be asingle-channel sleeve for use in single-level or multi-level spinalstabilization procedures. Sleeve 244 may be used at the outermostvertebrae to be stabilized during installation of a multi-levelvertebral stabilization system. Sleeve 244 may be coupled to collar 112of bone fastener assembly 102 with movable members 252 and/or flange254. Instruments may be inserted through passage 250 of sleeve 244 toaccess an anchored bone fastener assembly coupled to sleeve 244. Aninstrument may be moved through channel 248 toward an adjacent vertebrato form a tissue plane in soft tissue between sleeve 244 and theadjacent vertebra.

Sleeve 244 may be coupled to bone fastener assembly 102 in various waysto inhibit movement of sleeve 244 relative to collar 112 of bonefastener assembly 102. A system used to couple sleeve 244 to bonefastener assembly 102 may inhibit rotation and translation of sleeve 244relative to collar 112.

FIG. 31 depicts a perspective view of sleeve 244 embodiment duringconnection of sleeve 244 to collar 112 of bone fastener assembly 102.Sleeve 244 may include movable members 252. Movable members 252 mayinclude threaded distal end portions. FIG. 31A depicts a detailed viewof a portion of sleeve 244 and collar 112. Collar 112 may includeopenings 260. Openings 260 may be threaded. Openings 260 of collar 112may be aligned with movable members 252. A drive end of driver 262 maybe positioned in tool engaging portion 256 of movable member 252. Driver262 may be rotated to couple a threaded end of movable member 252 withthreads in opening 260. Driver may be positioned in a tool opening ofsecond movable member 252. Driver may be used to couple a threaded endof second movable member 252 with threads in second opening 260.Threaded connections between movable members 252 and collar 112 mayinhibit movement of collar 112 relative to sleeve 244.

A detachable member may be coupled to collar 112 of bone fastenerassembly 102 in various ways. When a detachable member is coupled tocollar 112, rotation and translation of the detachable member relativeto collar 112 may be inhibited. A system used to couple a detachablemember and collar should be simple, inexpensive to implement, and shouldnot significantly weaken the mechanical strength of collar 112 and/orthe detachable member. Detachable members may be coupled to collarsusing various coupling systems including, but not limited to, flanges,threaded connections, interlocking connections (e.g., ratchetingconnection systems), and/or interference fits.

In one embodiment of an interlocking connection system, a detachablemember may include an opposing pair of deflectable arms. Eachdeflectable arm may include a tooth. The deflectable arms may be forcedoutwards during coupling of collar 112 to the detachable member. Whencollar 112 is coupled to the detachable member, the deflectable arms maybe positioned in channels in collar 112, with the teeth positioned inindentions in collar 112. The presence of the deflectable arms in thechannels of collar 112 may inhibit rotation and translation of thedetachable member relative to collar 112. Separation of the detachablemember from collar 112 may be achieved by insertion of an expander inthe detachable member. The expander may be used to force the deflectablearms outwards and expel the teeth from the indentions.

FIGS. 32-45 depict embodiments of sleeves coupled to bone fastenerassemblies. In each bone fastener assembly/sleeve embodiment depicted inFIGS. 32-43 and FIG. 45, elongated member 104 seated in collar 112 ofbone fastener assembly 102 would lie below a distal end of sleeve 244.Having elongated member 104 below the distal end of sleeve 244 reducesbulk at the surgical site. With sleeve 244 positioned above theelongated member, interference of the secured elongated member withsleeve 244 is avoided during removal of sleeve 244.

FIG. 32 depicts a cross-sectional representation of sleeve 244 includingsleeve flange 254. Sleeve 244 may be rotated onto collar 112 until slot150 aligns with channel 248. Sleeve flange 254 may engage flange 154 ofcollar 112 to inhibit translation of sleeve 244 relative to collar 112of bone fastener assembly 102.

In some embodiments, the detachable member and collar 112 may includemembers that work together to inhibit radial expansion of walls of thedetachable member. FIG. 33 depicts one embodiment of sleeve 244 coupledto one embodiment of bone fastener assembly 102. Sleeve 244 may includesleeve flange 254 and stop 258. Sleeve flange 254 may engage flange 154of collar 112 to inhibit translation of sleeve 244 relative to collar112. Stop 258 may contact ledge 264 of collar 112. Contact of stop 258against ledge 264 may inhibit release of collar 112 from sleeve 244caused by radial expansion of walls of sleeve 244. Stop 258 in sleeve244 and ledge 256 in collar 112 may be needed in a multi-channel sleeveembodiment. Stop 258 in sleeve 244 and/or ledge 256 in collar 112 maynot be needed in a single-channel sleeve embodiment or collar 112 for asingle-level stabilization. In some embodiments, a detachable member mayinclude a protrusion that mates with a complementary groove in collar112. Alternatively, a detachable member may include a groove that mateswith a complementary protrusion of collar 112. FIG. 34 depicts across-sectional view of sleeve 244 with ridge 266. Ridge 266 may couplewith groove 268 in collar 112. Ridge 266 and groove 268 may form adovetail joint. The dovetail joint may inhibit radial expansion ofsleeve walls 246. In some embodiments, such as the embodiment depictedin FIG. 35, ridge 266 and groove 268 may not form a dovetail joint.

In some embodiments, a detachable member and/or collar 112 may include alocking system to inhibit rotation of the detachable member relative tocollar 112. The locking system may be, but is not limited to, threading,interference fits, frictional engagement, or a press-fit connection. Insome embodiments, a locking system may inhibit translation and/orrotation of a detachable member relative to collar 112.

FIG. 36 depicts a top view representation of one embodiment of collar112 of bone fastener assembly 102. Collar 112 includes openings 260. Insome embodiments, openings 260 may be threaded. In some embodiments,openings 260 may not include threading. The body of collar 112 adjacentto openings 260 may include extra material to provide strength to collar112.

FIG. 37 depicts a partial cross-sectional representation of oneembodiment of sleeve 244 coupled to one embodiment of collar 112, suchas collar 112 depicted in FIG. 36. Distal end portions of movablemembers 252 may extend into openings 260. When distal end portions ofmovable members 252 are positioned in openings 260, rotational movementof sleeve 244 relative to collar 112 may be inhibited. Sleeve 244 mayinclude flange 254. Flange 254 may engage flange 154 of collar 112 toinhibit translation of sleeve 244 relative to collar 112. In oneembodiment in which distal end portions of movable members 252 in sleeve244 are threaded and openings in collar 112 are threaded, rotation andtranslation of collar 112 relative to sleeve 244 may be inhibited whendistal end portions of movable members 252 are positioned in openings260.

In some embodiments, portion 270 of movable member 252 may includethreading. Threading of portion 270 may engage threading in wall 246 ofsleeve 244. Engagement of threading of portion 270 with threading inwall 246 may allow distal end portion of movable member 252 to advancetowards, or retract from, a distal end of sleeve 244 when movable member252 is rotated.

FIG. 38 depicts a top view representation of one embodiment of collar112 of bone fastener assembly 102. Collar 112 may include notches 156.FIG. 39 depicts a partial cross-sectional representation of oneembodiment of sleeve 244 coupled to one embodiment of collar 112, suchas collar 112 depicted in FIG. 38. Distal end portions of movablemembers 252 of sleeve 244 may be extended and positioned in notches 156of collar 112. An interference fit between the distal end portions ofmovable members 252 and the body of collar 112 that defines the notchesmay inhibit rotation of sleeve 244 relative to collar 112.

In one embodiment portion 270 of movable member 252 may includethreading. Threading of portion 270 may engage threading in wall 246 ofsleeve 244. Engagement of threading of portion 270 with threading inwall 246 may allow a distal end portion of movable member 252 to advancetowards, or retract from, a distal end of sleeve 244 when the movablemember is rotated.

In one embodiment, an inner sleeve may be positioned in sleeve 244 toinhibit translation and/or rotation of sleeve 244 relative to collar 112of bone fastener assembly 102. FIG. 40 depicts a cross-sectional view ofsleeve 244 with inner sleeve 272. A distal end of inner sleeve 272 maycontact an upper end of collar 112. A proximal portion of inner sleeve272 may engage a proximal portion of sleeve 244. The engagement mayallow inner sleeve 272 to apply a force against collar 112 that pressesflange 154 against flange 254 of sleeve 244 to inhibit translation ofsleeve 244 relative to collar 112. The engagement may be, but is notlimited to, a threaded connection, an interference fit, a frictionalfit, or a keyway type of connection.

In some embodiments, a distal end of inner sleeve 272 may be roughenedor textured to frictionally engage a proximal surface of collar 112. Thefrictional engagement may inhibit rotation of sleeve 244 relative tocollar 112. In some embodiments, inner sleeve 272 may include passage274. A pin may pass through passage 274 into an opening in collar 112.When a pin is positioned through passage 274 into the opening, rotationof sleeve 244 relative to collar 112 may be inhibited.

In some embodiments, threading may be used to couple a detachable memberto collar 112. FIG. 41 and FIG. 42 depict partial cross-sectionalrepresentations of sleeves 244 that couple to collars 112 by threadedconnections. Sleeves 244 may include female threading that iscomplementary to male threading of collar 112. In some embodiments,threading of sleeve 244 and threading of collar 112 may be modifiedthreads.

FIG. 43 depicts a partial cross-sectional representation of sleeve 244that couples to collar 112 by a threaded connection. Sleeve 244 mayinclude male threading, and collar 112 may include complementary femalethreading. In some embodiments, portion 276 of collar 112 that includesthreading which mates with threading of sleeve 244 may be a break-offsection. Collar 112 may be held in a fixed position. Torque may beapplied to sleeve 244 to shear off portion 276.

In some embodiments, a detachable member may include a pair of hingedarms configured to couple to collar 112. FIG. 44 and FIG. 45 depictembodiments of sleeves that include hinged portions. Sleeve 244 mayinclude arms 278. Arms 278 may be pivotally coupled together by hinge280. Hinge 280 may be located near a proximal end of sleeve 244. In somesleeve embodiments, sleeve 244 may include a locking element or abiasing element (e.g., a spring) near or at hinge 280. A locking elementor biasing element may cause a clamping force to be exerted on collar112 to maintain collar 112 in sleeve 244 and/or to inhibit rotation ofcollar 112 in sleeve 244. In some embodiments, such as in the embodimentdepicted in FIG. 44, flange 254 of sleeve 244 may contact a bottomportion of collar 112. In some embodiments, such as in the embodimentdepicted in FIG. 45, flange 254 of sleeve 244 may contact flange 154 ofcollar 112.

In some detachable member embodiments, proximal portions of detachablemembers may be chamfered to allow ends of the detachable members to moreclosely approach each other than detachable members with a uniform crosssection. FIG. 46 depicts sleeves 244 coupled to collars 112 engaged inadjacent pedicles 164. Sleeves 244 may include chamfered surfaces 282.Chamfered surfaces 282 may reduce space between proximal ends of sleeves244. During some surgical procedures, only one of sleeves 244 may bechamfered. During some surgical procedures, the use of sleeve 244 with achamfered surface may allow for a smaller incision than required whenusing non-chamfered sleeves. In some embodiments, other types ofdetachable members may be used to reduce space between proximal ends ofdetachable members. Other types of detachable members may include, butare not limited to, detachable members of different lengths, detachablemembers of different diameters, and detachable members with flexible endportions.

Detachable members may be of various lengths. Detachable members ofdifferent lengths ay be used in the same surgical procedure. Adetachable member length used in a spinal stabilization procedure may bedetermined by a patient's anatomy. Detachable members may be just shortenough to allow manipulation by a medical practitioner above an incisionin a patient. In some embodiments, detachable members may be about 3.5to about 11.5 cm long. For example, a single-channel detachable membermay be about 10 cm long. In some embodiments, detachable members may beabout 11.5 cm to about 14 cm long. For example, a single-channel or amulti-channel detachable member may be about 12.5 cm long. Amulti-channel detachable member may be longer than a single-channeldetachable member. In some embodiments, a multi-channel detachablemember may be at least about 15 cm long. For example, a multi-channeldetachable member may be about 16 cm long. Detachable members that aretoo long may require a longer incision and/or a larger tissue plane forinsertion of a spinal stabilization system. Insertion of elongatedmember 104 may be more difficult with detachable members that are longerthan necessary. Detachable members with excess length may be bulky andhard to manipulate during a surgical procedure.

A detachable member may be flexible over its entire length or include aflexible portion near a proximal end of the detachable member. Aflexible portion may allow positioning of a proximal portion of adetachable member in a desired location. A flexible portion may beproduced from any of various materials including, but not limited to, asurgical grade plastic, rubber, or metal. A flexible portion may beformed of various elements, including, but not limited to, a tube, achannel, or a plurality of linked segments.

FIG. 47 depicts one embodiment of sleeve 244 with a connection thatallows movement of first portion 284 relative to second portion 286.First portion 284 may be coupled to collar 112 of bone fastener assembly102. Second portion 286 may connect to first portion 284 at linkage 288.Linkage 288 may include, but is not limited to, a locking element, apivot point, a hinge, or a pin. In some embodiments, the linkage may bea ball and socket type of connection that allows rotational motion ofsecond portion 286 relative to first portion 284. During some spinalstabilization procedures, a detachable member without a second portionthat is able to move relative to a first portion may be used at onevertebra, and a detachable member with a second portion that is able tomove relative to a first portion may be used at one or more vertebraethat are to be stabilized.

When bone fasteners 108 of polyaxial bone fastener assemblies 102 arepositioned in vertebral bone, detachable members coupled to collars 112of bone fastener assemblies 102 may be moved in desired positions.During surgery, detachable member in a patient may be oriented towardsan adjacent vertebra that is to be stabilized to reduce the requiredincision size. In some embodiments, channels of the detachable membersmay be aligned so that elongated member 104 may be positioned in collars112 of bone fastener assemblies 102. FIG. 48 depicts an orientation ofthree sleeves 244. Sleeves 244, 244′ may couple to collars 112, 112′.Bone fasteners 108, 108′ may be inserted into vertebrae. Single-channelsleeves 244 may be coupled to collars 112 before insertion of bonefasteners 108 into two outer pedicles to be stabilized. Multi-channelsleeve 244′ may be coupled to collar 112′ before insertion of bonefastener 108′ into a central pedicle of the three adjacent pedicles.Single-channel sleeves 244 may be angled towards multi-channel sleeve244′. In certain embodiments, multi-channel detachable members may becoupled to all three pedicles. In some embodiments, differently shapeddetachable members (e.g., circular, oval) may be used in one or more ofthe pedicles. Channels of sleeves 244 may be aligned so that elongatedmember 104 may be moved down sleeves 244 and into collars 112 of bonefastener assemblies 102.

In some embodiments, channels of detachable members may face a directionother than toward each other. FIG. 49 depicts sleeves 244 coupled tocollars 112 oriented at an angle so that channels 248 of sleeves 244face in different directions. Elongated member 104 may be curved in anappropriate shape to engage slots 150 in collars 112 when channels 248of sleeves 244 are angled. In some embodiments, channels 248 in sleeve244 may not be longitudinal channels 248 down the length of detachablemember 244. In some embodiments, channels 248 of two adjacent detachablemembers 244 may not face towards each other when the openings of collars112 coupled to detachable members 244 are aligned.

In one embodiment, a frame may couple to two or more detachable members.FIG. 50 depicts a perspective view of sleeves 244 coupled to frame 290.As used herein, a “frame” includes any of a variety of structuralelements including, but not limited, rods, bars, cages, or machinedblocks. In some embodiments, frame 290 may provide a rigid couplingbetween sleeves 244. In some embodiments, frame 290 may allow forangular or translational movement between sleeves. For example, frame290 may include slidable elements that allow sleeves to be translatedtoward each other or away from each other to facilitate compression ordistraction of vertebrae. Alternatively, frame 290 may enable sleeves244 to pivot toward each other or away from each other. In someembodiments, frame 290 may allow for movement of sleeves 244 tofacilitate spinal reduction.

After bone fastener assembly 102 is coupled to a detachable member, adriver may be coupled to a bone fastener of bone fastener assembly 102.The driver may be used to insert bone fastener 108 into vertebral bone.FIG. 51 depicts one embodiment of driver 292 positioned in sleeve 244.Sleeve 244 is coupled to bone fastener assembly 102. Driver 292 may becoupled to collar 112 and to bone fastener 108 of bone fastener assembly102. Coupling driver 292 to collar 112 and to bone fastener 108 mayensure proper alignment of driver 292 relative to bone fastener 108.Coupling driver 292 to collar 112 and to bone fastener 108 may alsoinhibit movement of collar 112 relative to bone fastener 108 duringinsertion of bone fastener 108.

Driver 292 may include outer shaft 294, inner shaft 296, and removablehandle 236. Outer shaft 294 may include threading 298 and texturedportion 300. A portion of outer shaft 294 may be positioned in a passagethrough sleeve 244 (passage 250 shown in FIG. 30). Threading 298 maycouple to a modified thread of collar 112. Textured portion 300 mayfacilitate rotation of outer shaft 294 so that threading 298 engages themodified thread of collar 112. When threading 298 engages the modifiedthread of collar 112, driver 292 may be securely coupled to bonefastener assembly 102, which is securely fastened to sleeve 244.

A distal end of inner shaft 296 may be coupled to bone fastener 108during use. Inner shaft 296 may be coupled at a proximal end toremovable handle 236 during use. Inner shaft 296 may be rotatablerelative to outer shaft 294 so that bone fastener 108 can be insertedinto vertebral bone. A proximal portion of inner shaft 296 may includeat least one flat portion that fits in a mating portion of removablehandle 236. Removable handle 236 may be the same removable handy; thatis used with bone tap 230 that forms a threaded opening in vertebralbone for bone fastener 108. Removable handle 236 may be removed fromdriver 292 during insertion of guide wire 218 through driver 292 so thatguide wire 218 may be held in at least one place at all times. In someembodiments, removable handle 236 for driver 292 may be unnecessarygiven the length of guide wire 218 and/or the length of driver 292(e.g., a long guide wire 218 and/or a short driver 292).

FIG. 52 depicts a cross-sectional representation of a portion of oneembodiment of a driver that is coupled to bone fastener 108 and collar112 of bone fastener assembly 102. Collar 112 is coupled to sleeve 244.Sleeve 244 is positioned in dilator 302. In some embodiments, clearancebetween outer shaft 294 and sleeve 244 may be relatively small. In someembodiments, the clearance between outer shaft 294 and sleeve 244 mayrange from about 0.1 mm to about 0.75 mm. For example, the clearancebetween outer shaft 294 and sleeve 244 may be about 0.25 mm (i.e., aninner diameter of sleeve 244 may be about 0.5 mm greater than an outerdiameter of the outer shaft). Also, clearance between sleeve 244 anddilator 302 may be relatively small. The small clearances may inhibitundesired movement of the instruments relative to each other and/orreduce bulkiness at the surgical site.

Thread 298 of outer shaft 294 of driver 292 may couple to modifiedthread 148 of collar 112. Head 304 of inner shaft 296 of driver 292 maycouple to tool portion 126 of bone fastener 108. Head 304 may have acomplementary shape to tool portion 126 of bone fastener 108. Guide wire218 may be inserted into a distal end of passage 114 of bone fastener108 and through passage 306 of the driver. When guide wire 218 isinserted into passage 114 and passage 306, removable handle 236 may notbe coupled to inner shaft 296.

During a minimally invasive surgical procedure, a plane may be createdin tissue from a first vertebra to a second vertebra. Elongated member104 may be positioned in the plane during the surgical procedure. Insome embodiments, a tissue plane may be formed using a targeting needle.The targeting needle may be positioned at the first vertebra. The distalend of the needle may be moved toward the second vertebra to form theplane while, maintaining a position of the needle at a surface of theskin. The needle may be moved back and forth a number of times to dearlyestablish the plane. Care may need to be taken to avoid bending thetargeting needle during establishment of the plane.

In some embodiments, a tissue wedge may be used to form a plane intissue between a first vertebra and a second vertebra. FIG. 53 depictsone embodiment of tissue wedge 308. Tissue wedge 308 may include handle310 and blade 312. Handle 310 may allow blade 312 to be easilypositioned at a desired location.

Blade 312 may be a double-wedged blade. Blade 312 may have adiamond-like shape. Edges of blade 312 may be blunt to avoid severingtissue during use of tissue wedge 308. Distal end 314 of blade 312 maybe rounded. A shape of distal end 314 may inhibit damage to tissue andmay facilitate movement of blade 312 towards a target location duringformation of a plane in tissue between vertebrae. In some tissue wedgeembodiments, tissue wedge 308 may include hook 316. Cutting edge 318 inhook 316 may be used to sever portions of tissue (e.g., fascia) throughwhich blade 312 cannot form a plane. Cutting edge 318 may be oriented inblade 312 so that severing of tissue results when tissue wedge 308 ispulled away from the spine.

An estimating tool may be used to estimate a distance between bonefastener assemblies anchored in vertebrae. Bone fastener assemblies 102may be part of a single-level or multi-level spinal stabilizationsystem. The distance estimated by an estimating tool may be used todetermine a desired length of elongated member 104 to be positioned incollars of the anchored bone fastener assemblies. FIG. 54 depicts oneembodiment of estimating tool 320 with handle 322 and shaft 324. Arms326 may be pivotably coupled to coupling portion 325 of shaft 324.Distal ends of arms 326 may be rounded. In some embodiments, distal endsof arms 326 may include members 330. Members 330 may be rounded (e.g.,spherical) or elongated (e.g., tubular). Members 330 may also have othershapes to meet specific needs or requirements. In embodiments, a shapeand/or a size of members 330 may be designed to fit snugly intodetachable members coupled to a spinal stabilization system.

Activator 328 may be located at a proximal end of handle 322. Withactivator 328 unengaged, a biasing element (e.g., a spring, springs,and/or elastic member) in coupling portion 325 may allow arms 326 toassume a fully extended position. With arms 326 in a fully extendedposition, members 330 may achieve a maximum separation distance.Estimating tool 320 may be designed such that a maximum separationdistance of members 330 exceeds an expected distance between anchoredbone fastener assemblies 102. Fully extended arms 326 may be manuallycompressed and inserted into passages of sleeves 244 coupled to anchoredbone fastener assemblies 102. For a multi-level system, arms 326 may beinserted in detachable members coupled to the outermost bone fastenerassemblies 102 while one or more detachable members coupled to one ormore inner vertebrae are held out of the way. With activator 328unengaged, the biasing element in coupling portion 325 may force members330 against inner walls of the detachable members.

Estimating tool 320 may be advanced toward anchored bone fastenerassemblies 102. In some embodiments, estimating tool 320 may be advancedtoward anchored bone fastener assemblies 102 until members 330 contactcollars 112 and/or bone fasteners 108 of bone fastener assemblies 102.With members 330 contacting collars 112 and/or bone fasteners 108,activator 328 of estimating tool 320 may be engaged. Engaging activator328 of estimating tool 320 may limit the biasing element such that thedistance between outer surfaces of members 330 does not exceed thedistance between anchored bone fastener assemblies 102. With activator328 engaged and the distance between outer surfaces of members 330 fixedto indicate the distance between anchored bone fastener assemblies 102,estimating tool 320 may be moved upwards to remove the estimating toolfrom the patient. When estimating tool 320 is moved upwards, arms 326may compress to facilitate removal of the estimating tool from thedetachable members.

Once removed from the detachable members, the biasing element mayrestore the distance between outer surfaces of members 330 to indicatethe separation between anchored bone fastener assemblies 102. Thedistance between members 330 (e.g., the distance between outer surfacesof the members) may be used to estimate a length of elongated member 104needed to couple the anchored bone fastener assemblies. The distancebetween members 330 may be read using a scale provided in theinstrumentation kit. In some embodiments, the scale may be indicia oretching on a surface of the instrumentation kit. In one embodiment, alength of elongated member 104 may be chosen to be greater than adistance between members 330 to allow for bending of elongated member104 and/or to allow elongated member 104 to extend beyond collars 112 ofanchored bone fastener assemblies 102. For example, 15 mm may be addedto the distance between members 330. In some embodiments, a length ofelongated member 104 may be chosen such that elongated member 104extends 2 mm or more beyond collars 112. In certain embodiments, alength of elongated member 104 may be chosen such that ends of elongatedmember 104 do not extend from collars 112.

In the embodiment shown in FIG. 55, arms 326 of engaging tool 320 may besubstantially parallel to each other and/or touching each other withactivator 328 unengaged. Engaging activator 328 may cause separation ofarms 326 at an angle, such that a distance between distal ends of arms326 is greater than a distance between proximal portions of arms 326.Estimating tool 320 may be inserted (e.g., with arms 326 together) indetachable members coupled to bone fastener assemblies 102 anchored invertebral bone. Activator 328 may be engaged and activated until arms326 extend through channels of the detachable members and contact innersurfaces of the detachable members. Arms 326 may contact bone fasteners108 in bone fastener assemblies 102. With arms 326 extended to meetresistance in the detachable members, estimating tool 320 may bewithdrawn from the detachable members. During withdrawal of estimatingtool 320 from the detachable members, arms 326 may be compressed towardeach other as the estimating tool is moved up the detachable members andout of the body. After withdrawal of estimating tool 320 from thedetachable members, arms 326 may extend back to the separation achievedwhen the arms were touching bone fasteners 108. The distance betweenextended arms 326 may be used to estimate a length of elongated member104 needed to couple anchored bone fastener assemblies 102.

In some embodiments, an estimating tool may include a gauge. FIG. 56depicts one embodiment of estimating tool 320 with gauge 332. With arms326 of estimating tool 320 positioned together, gauge 332 may have ormay be set to a zero reading. With arms 326 extended to meet resistancein sleeves 244, gauge 332 may provide an estimate of the distancebetween sleeves 244. The distance between sleeves 244 may be used toestimate a length of elongated member 104 needed to couple the anchoredbone fastener assemblies. In one embodiment, a length of elongatedmember 104 may be chosen to be greater than the distance measured by agauge to allow elongated member 104 to extend beyond slots of collars ofanchored bone fastener assemblies 102.

In some embodiments, elongated member positioner may be used to guideelongated member 104 through detachable members and to positionelongated member 104 in collars 112 proximate pedicles of vertebrae.FIG. 57 depicts one embodiment of elongated member positioner 334.Elongated member positioner 334 may include outer shaft 336, handle 338,inner shaft 340, and grasping member 342. In some embodiments, graspingmember 342 may be a hook. A first end (i.e., proximal end) of outershaft 336 may be connected to handle 338. A second end (i.e., distalend) of outer shaft 336 may be coupled to grasping member 342. Innershaft 340 may pass through handle 338 and outer shaft 336. A second end(i.e., distal end 344) of inner shaft 340 may contact elongated member104 positioned in grasping member 342. A first end (proximal end 346) ofinner shaft 340 may extend from handle 338. Proximal end 346 of innershaft 340 may be a knob or a thumb plate. An amount of force applied toelongated member 104 positioned between grasping member 342 and distalend 344 of inner shaft 340 may be controlled by the amount of pressureapplied to proximal end 346 of inner shaft 340. Pressure may be appliedto proximal end 346 of inner shaft 340 manually or mechanically.Mechanical means of applying pressure to proximal end 346 of inner shaft340 include, but are not limited to, forceps handles and an adjustablerotor.

Distal end 344 of inner shaft 340 may be positioned proximate graspingmember 342. Elongated member 104 may be positioned between graspingmember 342 and distal end 344 of inner shaft 340 of positioning tool 334before or after initial insertion of elongated member 104 into sleeve244. Elongated member 104 may be held between grasping member 342 anddistal end 344 of inner shaft 340 with pressure applied to proximal end346 of inner shaft 340. Distal end 344 of inner shaft 340 may becontoured (e.g., curved) to allow some motion (e.g., rocking motion) ofelongated member 104 while elongated member 104 is coaxed into positionwith positioning tool 334. During some installation procedures,positioning tool 334 may remain coupled to elongated member 104 untilelongated member 104 is secured in collars 112 of anchored bone fastenerassemblies 102 with closure members 106.

In some cases, pressure supplied to elongated member 104 with elongatedmember positioner 334 may not be sufficient to seat elongated member 104in collar 112. A seater may be used in conjunction with elongated memberpositioner 334 to maneuver elongated member 104 into one or morecollars. During some procedures, elongated member positioner 334 may beremoved from elongated member 104 before using the seater. During someprocedures, elongated member positioner 334 may remain attached toelongated member 104 until closure members 106 are secured to bonefastener assemblies 102 to form a spinal stabilization system.

Seater 348, shown in FIG. 58, may include handle 350 and groove orgrooves 352. A portion of elongated member 104 to be positioned incollars 112 may fit in grooves 352. In one embodiment, elongated memberpositioner 334 may be used to align elongated member 104 proximate slotsin one or more collars 112 coupled to pedicles of vertebrae. Groove 352of seater 348 may be positioned at a desired position along a length ofelongated member 104. A user may apply downward force with handle 350 toseat elongated member 104 in collar 112 as elongated member positioner334 is used to guide elongated member 104 into position.

After elongated member 104 has been positioned and seated in collars 112as desired, closure members 106 may be used to secure elongated member104 to collars 112. FIGS. 59A and 59B depict perspective views of driver354. Driver 354 may be used to position closure member 106 in collar 112of bone fastener assembly 102. As shown in FIG. 59A, driver 354 mayinclude handle 356, elongated portion 358, and coupling portion 360.Coupling portion 360 may be used to engage closure member 106. Couplingportion 360 may engage tool portion 170 of closure member 106, shown inFIG. 59B. In some embodiments, driver 354 may include an inner shaft.The inner shaft may couple closure member 106 to driver 354. The innershaft may couple to the tool portion of closure member 106 so that toolportion 170 is securely held after tool portion 170 is sheared fromclosure member 106. In some embodiments, an end of inner shaft may bepress fit into tool portion 170. In some embodiments, the inner shaftmay include a threaded end portion that engages a mating thread in toolportion 170. Rotation of the inner shaft may allow closure member 106 tobe locked in coupling portion 360 of driver 354. Knob 362 may be used torotate the inner shaft.

FIG. 60A depicts driver 354 with coupled closure member 106 positionedfor insertion in sleeve 244. After insertion of driver 354 in sleeve244, closure member 106 may be positioned proximate collar 112. Withdriver 354 positioned in sleeve 244, as shown in FIG. 60B, the drivermay be rotated to advance closure member 106 in collar 112 and secureelongated member 104 to collar 112. When closure member 106 is snug andelongated member 104 is secured, driver 354 may be disengaged fromclosure member 106 and removed from sleeve 244. In one embodiment,driver 354 may be used to shear off tool portion 170 of secured closuremember 106. In some embodiments, the coupling portion of driver 354 maycapture sheared tool portion 170 of closure member 106. In certainembodiments, driver 354 may include a mechanism to dislodge closuremember 106 and/or tool portion 170 of closure member 106 from the distalend of driver 354.

In some embodiments, a detachable member may be held with a countertorque wrench as the tool portion of closure member 106 is sheared off.In one embodiment, about 90 in-lbs of torque may be required to shearoff tool portion 170 of closure member 106. A counter torque wrench mayinhibit transfer of force to the patient when closure member 106 isbeing secured to collar 112. FIG. 61 depicts one embodiment of countertorque wrench 364 used to inhibit application of torque to a patient'sspine during shearing of a tool portion of a secured closure member.Sleeve 244 may fit in opening 366 of counter torque wrench 364. Countertorque wrench 364 may be positioned near a proximal end of sleeve 244during use. Force may be applied to counter torque wrench 364 in adirection opposite to rotational force applied to driver 354 to shearoff the tool portion of a secured closure member. Opening 366 in torquewrench 364 may be of any shape to accommodate a cross-sectional shape ofsleeve 244 and inhibit rotation of sleeve 244 during use.

FIG. 62 depicts one embodiment of counter torque wrench 368 designed toaccommodate sleeves. Counter torque wrench 368 may include hollow shaft370 and handle 372. Groove 374 may be located at a distal end of hollowshaft 370. FIG. 63 depicts counter torque wrench 368 fitted overmulti-channel sleeve 244. In one embodiment, hollow shaft 370 may beinserted through an opening in the body over sleeve 244 and advancedtoward the spine until elongated member 104 is seated in groove 374.Counter torque wrench 368 may engage the spinal stabilization system.Force may be applied to counter torque wrench 368 in a directionopposite to rotational force applied to driver 354 used to shear offtool portion 170 of secured closure member 106. During a minimallyinvasive spinal stabilization procedure, counter torque wrench 368 maybe used with various types of detachable members, includingsingle-channel sleeves 244 and multi-channel sleeves 244.

Minimally invasive procedures may involve locating a surgical site and aposition for a single skin incision to access the surgical site. Theincision may be located above and between (e.g., centrally between)vertebrae to be stabilized. An opening under the skin may be enlarged toexceed the size of the skin incision. Movement and/or stretching of theincision, bending of an elongated member, and angulation of collars 112of bone fastener assemblies 102 may allow the length of the incisionand/or the area of a tissue plane to be minimized. In some embodiments,minimally invasive insertion of a spinal stabilization system may not bevisualized. In certain embodiments, insertion of a spinal stabilizationsystem may be a top-loading, mini-opening, muscle-splitting, screwfixation technique.

In some embodiments, insertion of a spinal stabilization system mayinclude gradually increasing the diameter of an opening formed in apedicle and/or vertebral body to accept bone fastener assembly 102. Insome embodiments, targeting needle 198 may have outer diameter of aboutD. In some embodiments bone awl 222 inserted after targeting needle 198may have an outer diameter incrementally larger than the outer diameterof targeting needle 198. As used herein, an incrementally largerdiameter may be large enough to allow a snug but adjustable fit. Forexample, bone awl 222 may have outer diameter of about (D+x). A tapportion of bone tap 230 inserted after bone awl 222 may have a minordiameter of about (D+2x). Bone fastener 108 may have a minor diameter ofabout (D+3x). In some embodiments, x may be between about 0.1 mm andabout 1.0 mm. For example, x may be about 0.5 mm. Incremental sizing oftargeting needle 198, bone awl 222, tap 230, and bone fastener 108 maypromote a proper fit of bone fastener 108 in the vertebra to bestabilized.

In one embodiment of a spinal stabilization system insertion method, thepatient may be placed in a prone position on a radiolucent table withclearance available for a C-arm of a fluoroscope. For example, a Jacksontable with a radiolucent Wilson frame attachment may be used. Theability to obtain high quality images is very important. Bolsters,frames, and pads may be inspected for radiolucency prior to theoperation. Placing the patient in a knee-chest position (e.g., using anAndrews table) should be avoided. Care should be taken to avoid placingthe patient's spine in kyphosis during positioning of the patient.

The C-arm of the fluoroscope should be able to freely rotate between theanteroposterior, lateral, and oblique positions for optimalvisualization of pedicle anatomy during the procedure. The arm should herotated through a full range of motion prior to beginning the procedureto ensure that there is no obstruction or radio-opaque object in theway. The fluoroscope may be positioned so that Ferguson views and “bullseye” views are obtainable. Once the patient is positioned and theability to obtain fluoroscopic images of the target levels forinstrumentation has been confirmed, the patient may be prepared anddraped sterilely.

For most of the lumbar region, the vertebral pedicle is an obliquelyoriented cylindrical corridor. The angulation varies by approximately 5degrees per level (e.g., 5 degrees; L5: 25 degrees). A pre-operativefine-cut computed tomography image may be examined to determine anyunique anatomy of the patient. Acquiring the pedicle in the most lateraland superior quadrant of the pedicle may be desirable to avoid theoverriding facet during a minimally invasive procedure. A lateral entrypoint may allow for better screw convergence as well as lessinterference with the superior adjacent level facet joint. A targetingneedle may be passed in a medial and inferior trajectory, thus followingthe natural pathway of the pedicle. Frequent fluoroscopic inspection inboth an anteroposterior and lateral plane may ensure proper passage ofthe needle as the needle is inserted into vertebral bone.

Various techniques may be used to plan the skin incisions and entrypoints. In one embodiment, the planning sequence form single-levelstabilization may include the following four steps. First, ananteroposterior image may be obtained with the spinous processescentered at the target vertebral bodies. Vertical lines passing throughmidpoints of pedicles that are to receive bone fasteners may be markedon the patient. The lines do not represent skin entry points. The linesare markers of pedicle entry points used to estimate angles at whichtargeting needles to be inserted to contact the pedicles. In someembodiments, sets of vertical lines may be drawn corresponding to thelateral edges of the pedicles instead of lines corresponding to themidpoints of the pedicles.

Second, horizontal lines may be marked approximately through the centersof the pedicles (mid-pedicle lines) on the patient. In some embodiments,the lines may be drawn on the superior side of the center axes (superiorto the mid-pedicle).

Third, an oblique or “bulls eye” view (i.e., down a longitudinal axis ofa pedicle) may be obtained on each side of the patient for each pediclethat is to be stabilized. Vertical oblique view lines may be marked onthe skin at the midpoints of each of the pedicles that are to receive abone fastener. The oblique view lines may be drawn in a different colorthan the vertical lines drawn during the first step. In someembodiments, vertical lines may be drawn corresponding to the lateraledges of the pedicles instead of lines corresponding to the midpoints ofthe pedicles.

The oblique view lines may be about 2 cm to about 3 cm away from thelateral pedicle border lines marked in the first step. For largerpatients, the oblique view line may be greater than about 3 cm away fromthe midline marked in the first step. For smaller patients, the obliqueview line may be closer than about 2 cm away from the midline marked inthe first step. The intersection of the oblique view lines with thehorizontal lines drawn in the second step may represent skin entrypoints for a targeting needle as the targeting needle passes throughsoft tissue at an angle towards the bony pedicle entry point. A sidefluoroscopic image, the horizontal lines, and the vertical lines mayhelp the surgeon triangulate between the skin entry points and bonyentry points.

Fourth, an incision may be made in he skin between mid-pedicle linesalong the vertical oblique view lines. The skin incision may be fromabout 2 cm to about 4 cm long. In some embodiments, the incision may befrom about 2.5 cm to about 3 cm long. Limiting the length of theincision may enhance patient satisfaction with the procedure. Theincisions may be pre-anesthetized with, for example, 1% lidocaine with1:200,000 epinephrine. To blunt the pain response, a long spinal needlemay be used to dock on the bone entry point and inject the Warmed musclepath in a retrograde fashion as well. Once the incision has been made,tissue surrounding the incision may be pulled and/or stretched to allowaccess to a target location in a vertebra.

After sterile preparation and draping, the pedicle entry points may befluoroscopically rechecked to ensure that the previously marked linescorrespond to the intersection of the midline of the transverse processand the lateral joint and pars interarticularis. The intersection of thefacet and the transverse process provides a starting point that may helpavoid the canal and follow the natural inclination of lumbar pedicles.For the spinal stabilization system described, in which sleeves 244coupled to bone fastener assemblies 102 are substantially unconstrainedby insertion angles of bone fasteners 108, patient anatomy may determinethe most advantageous insertion angles of bone fasteners 108.

A scalpel may be used to make a stab wound at the junction of an obliqueview line and a mid-pedicle In one embodiment, the scalpel may be a #11scalpel. Targeting needle 198 may be passed through the incision in anoblique lateral to medial trajectory towards the bony entry pointdefined by a lateral pedicle border line. The C-arm of the fluoroscopemay be placed in an anteroposterior position for this maneuver.

As targeting needle 198 encounters the bony anatomy, anteroposteriorfluoroscopic images may be used to place the tip of targeting needle 198at the upper outer quadrant of the pedicle. In some embodiments,targeting needle 198 may be walked medially along the transverse processto the pedicle entry point. In some embodiments, tip of targeting needle198 may be docked by lightly tapping the tip into the bone with a malletor other impact device to drive the tip into the bone. In someembodiments, tip of targeting needle 198 may be docked by applyingdownward pressure to targeting needle 198 to force the tip into thebone.

The fluoroscope may then be moved to a lateral position. The surgeon maycorrect the sagittal trajectory of targeting needle 198 by movingtargeting needle 198 in an anterior or posterior direction to match thevector of the pedicle corridor. In some embodiments, a mallet or otherimpact device may be used to gently advance targeting needle 198 intothe pedicle halfway to the pedicle-vertebral body junction. In someembodiments, force may be applied to targeting needle 198 to drivetargeting needle 198 into the pedicle halfway to the pedicle-vertebralbody junction. An anteroposterior image may then be obtained to confirmthat targeting needle 198 is approximately halfway across the pedicle inthe anteroposterior view. If the tip is more than halfway across thepedicle in a lateral to medial projection, the trajectory may be toomedial. Further advancement of targeting needle 198 may risk passingtargeting needle 198 through the spinal canal. Targeting needle 198 maybe repositioned. A new starting point or new trajectory may be obtained.If the anteroposterior image demonstrates that targeting needle 198 issignificantly lateral in the pedicle, then targeting needle 198 may havepassed along the lateral portion of the pedicle. Targeting needle 198that has passed along the lateral portion of the pedicle may bewithdrawn and repositioned.

Once a good trajectory has been obtained, targeting needle 198 may beadvanced using a mallet. In some embodiments, targeting needle 198 maybe pushed in without a mallet. Targeting needle 198 may be advanced tothe junction of the pedicle and vertebral body under lateralfluoroscopic guidance. FIG. 64A depicts targeting needle 198 advanced tothe junction of pedicle 164. At this point, confirmation of position andtrajectory should be repeated under anteroposterior fluoroscopy.Targeting needle 198 may be further advanced to a desired depth withinvertebral body 166 using a mallet or applied force. FIG. 64B depictstargeting needle 198 advanced to the desired depth.

A scale on targeting needle 198 may be used to approximate a length of abone fastener to be used. A first depth of targeting needle 198 may bemeasured relative to body surface 376 when pedicle 164 is firstencountered. A second depth of targeting needle 198 may be measuredrelative to body surface 376 after the targeting needle has beenadvanced to the desired depth in vertebral body 166. An approximatelength of bone fastener 108 to be used may be determined by taking adifference between the depth measurements.

After targeting needle 198 has been advanced into the bone, member 202of the targeting needle (shown in FIG. 64B) may be removed from thetargeting needle. FIG. 64C depicts outer housing 200 with member 202removed. After removal of member 202, guide wire 218 may be placedthrough a passage in targeting needle 198 into vertebral body 166. FIG.64D depicts targeting needle 198 with guide wire 218 positioned throughthe passage in the targeting needle 198. Lateral fluoroscopic images maybe obtained to indicate the position of guide wire 218. In someembodiments, guide wire 218 may be pushed into vertebral body 166. Incertain embodiments, guide wire 218 may be advanced about 1 cm beyond anend of outer housing 200 to secure targeting needle 198 in vertebralbody 166. In some embodiments, a small diameter tissue dilator may beplaced over guide wire 218 and positioned on an upper surface oftargeting needle 198. The tissue dilator may provide stability to guidewire 218. Added stability from the dilator may allow guide wire 218 tobe successfully tapped into the vertebral body with a small mallet. Careshould be taken to avoid kinking guide wire 218. After guide wire 218 issecured in vertebral body 166, outer housing 200 may be removed from thepatient. FIG. 64E depicts guide wire 218 after removal of targetingneedle 198.

Once guide wire 218 has been passed through the targeting needle and thetargeting needle has been removed, guide wire 218 may be used as a guideto position one or more successively sized dilators around a targetlocation in a pedicle. A dilator may be a conduit with a regular shape(e.g., cylindrical) or an irregular shape (e.g., C-shaped). A dilatormay form an opening through soft tissue to the pedicle. For patientswith a thick fascia, it may be advantageous to make a nick in the fasciawith a scalpel blade to facilitate passage of the dilators. The dilatorsmay be passed sequentially over the guide wire. The dilators may berotated during insertion to facilitate dilation of surrounding tissue.The dilators may be inserted until the leading edges contact thepedicle. A distal end of a dilator may be tapered to facilitatepositioning of the dilator proximate the pedicle. An instrumentation setfor a spinal stabilization system may include two, three, four, or moresuccessively sized dilators.

FIG. 65A depicts first dilator 302A positioned around guide wire 218.First dilator 302A may have an inner diameter just slightly larger thanan outer diameter of guide wire 218. As used herein, “an inner diameterjust slightly larger than an outer diameter” may mean that the innerdiameter is between about 0.03 mm and about 1.0 mm greater than theouter diameter. For example, an inner diameter of first dilator 302A maybe about 0.5 mm greater than the outer diameter of guide wire 218. FIG.65B depicts second dilator 302B positioned around first dilator 302A.Second dilator 302B may have an inner diameter just slightly larger thanan outer diameter of first dilator 302A. FIG. 65C depicts third dilator302C and fourth dilator 302D and positioned around second dilator 302B.Third dilator 302C may have an inner diameter just slightly larger thanan outer diameter of second dilator 302B. Fourth dilator 302D may havean inner diameter slightly larger than an outer diameter of thirddilator 302C. Once fourth dilator 302D is in position, dilators 302A.302B, 302C may be removed, starting with dilator 302A. Lengths ofdilators in a successively sized set may decrease with increasingdiameter to facilitate removal of the smaller dilators. Care should betaken to avoid dislodging guide wire 218 during insertion and removal ofthe dilators. FIG. 65D depicts fourth dilator 302D positioned aroundguide wire 218 following removal of dilators 302A, 302B, 302C.

After tissue dilation has been achieved, a large diameter dilator (e.g.,third dilator 302C or fourth dilator 302D shown in FIG. 65C) may be usedto guide bone fastener assembly 102 and/or insertion instruments towarda target location in a pedicle. FIGS. 66A-66F depict portions of aprocedure for preparation of pedicle 164 and vertebral body 166 forreceiving bone fastener assembly 102. FIG. 66A depicts bone awl 222positioned over guide wire 218 in dilator 302 such that a tip of boneawl 222 is on or near a surface of pedicle 164. Bone awl 222 may bedriven downwards into pedicle 164 to breach cortical bone of thepedicle. FIG. 66B depicts a position of bone awl 222 after pedicle 164has been breached. After pedicle 164 is breached, bone awl 222 may beremoved from dilator 302. FIG. 66C depicts guide wire 218 and dilator302 after removal of bone awl 222. In some embodiments, an initialpassage may be formed in the pedicle and the vertebral body using adrill or a drill and tap combination.

FIG. 66D depicts tap 230 positioned in dilator 302. After pedicle 164 isbreached, tap 230 may be inserted over guide wire 218 into dilator 302.In one embodiment, dilator 302 may be third dilator 302C. Tap 230 may besized to fit snugly inside third dilator 302C. In some embodiments,dilator 302 may be fourth dilator 302D. In certain embodiments, fourthdilator 302D may be inserted over third dilator 302C after bone has beentapped through the third dilator. Tapping through third dilator 302Crather than fourth dilator 302D may introduce less bulk at the targetsite of a pedicle during the tapping procedure. In some embodiments, anouter diameter of sleeve 244 coupled to bone fastener assembly 102 to beinserted in the pedicle may be substantially the same as an outerdiameter of third dilator 302C.

Tap 230 may include removable handle 236 and indicia 240. Indicia 240may be a scale. When tap 230 is positioned such that a first threadflight contacts pedicle 164, a first measurement of the position of thetap relative to a top of dilator 302 using indicia 240 may be noted. Tap230 may be rotated to form a threaded passage through pedicle 164 andinto vertebral body 166 to a desired depth. In some embodiments, alength of the threaded portion of tap 230 may be used to determine adepth of a threaded passage formed in a bone. For a threaded portion ofa known length (e.g., 30 mm, 45 mm, 60 mm), a scaled image (e.g., X-rayimage) of a depth of the threaded portion in a bone monitored duringtapping may allow a medical practitioner to determine the depth of thethreaded passage. In some embodiments, tap 230 may form threads of majordiameter about 0.5 mm smaller than a major diameter of threads of bonefastener 108 to be inserted into the threaded passage.

FIG. 66E depicts a position of tap 230 after a threaded passage of adesired length has been formed in pedicle 164 and vertebral body 166.Care should be exercised to ensure that guide wire 218 is not bent orkinked during the tapping process. The position of tap 230 relative tothe end of guide wire 218 may be monitored to ensure that guide wire 218is not dislodged or removed from the vertebra. In some embodiments, aposition of tap 230 may be monitored using fluoroscopic imaging.

After a threaded passage of a desired length has been formed in pedicle164 and vertebral body 166, a second measurement of the position of tap230 relative to a top of dilator 302 using indicia 240 may be noted. Alength of a threaded member may be determined by taking a differencebetween the first and second measurements. In some embodiments, anestimate of length may be derived based upon fluoroscopic images and aknown length of the tap that is visibly recognizable in the fluoroscopicimages. Tap 230 may be removed from vertebral body 166 and pedicle 164by rotating the tap out of the vertebral body and the pedicle. Handle236 may be removed from a blade portion of tap 230. The blade portion oftap 230 may be removed from guide wire 218 with control of the guidewire initially maintained from above tap 230 and then from below tap230. Care may be taken when tap 230 is removed to maintain guide wire218 in position and to avoid damage of guide wire 218. FIG. 66F depictsdilator 302 and guide wire 218 after removal of tap 230.

Bone fastener assembly 102 with bone fastener 108 of an appropriatelength may be selected for insertion in a patient. The size of bonefastener 108 may be verified with measurement indicia in aninstrumentation set. In some embodiments, measurement indicia may beetched or printed on a portion of an instrumentation set. For example,the chosen bone fastener embodiment may be placed over the outline of abone fastener embodiment printed on a tray of the instrumentation set.

The chosen bone fastener assembly 102 may be attached to a detachablemember. In one embodiment, bone fastener assembly 102 may be rotated ona flange of a detachable member. Movable members of the detachablemember may be extended into indentations in collar 112 of bone fastenerassembly 102. A driver may be used to extend the movable members tocouple with collar 112. When bone fastener assembly 102 is coupled tothe detachable member, a drive portion of a fastener driver may becoupled to a tool portion of bone fastener 108. A shaft of the fastenerdriver may be positioned in the passage of the detachable member. Aremovable handle may be attached to the shaft of the fastener driver.The detachable member, collar 112, and bone fastener 108 may besubstantially co-axial when the fastener driver is positioned in thedetachable member. In some embodiments, removable handle 236 may beattached to the shaft of the fastener driver after bone fastener 108,collar, detachable member, and fastener driver combination is positioneddown guide wire 218 through dilator 302 and against a pedicle.

FIGS. 67A-67D depict portions of a procedure for inserting bone fastenerassembly 102 into a patient. Driver 292 (coupled to bone fastener 108),and sleeve 244 (coupled to collar 112 of bone fastener assembly 102) maybe inserted along guide wire 218 into dilator 302. For spinalstabilization procedures using four successively sized dilators, dilator302 may be fourth dilator 302D. Guide wire 218 represents the trajectorythat hone fastener 108 or bone fastener assembly 102 may follow towardpedicle 164 during insertion of a spinal stabilization system. In someembodiments, tissue surrounding the incision may be pulled and/orstretched to allow a desired angular orientation of bone fastenerassembly 102 relative to pedicle 164. FIG. 67A depicts driver 292 andsleeve 244 positioned in dilator 302. After insertion of bone fastenerassembly 102, sleeve 244, and driver 292 in dilator 302, driver 292 maybe rotated to thread bone fastener 108 into pedicle 164 and vertebralbody 166. Bone fastener 108 may be advanced into the pedicle underfluoroscopic guidance to inhibit breaching of the pedicle walls. Whenthe tip of bone fastener 108 advances beyond the posterior margin ofvertebral body 166, guide wire 218 may be removed to inhibit inadvertentbending of guide wire 218 or unwanted advancement of guide wire 218.

Bone fastener 108 may be advanced to bring collar 112 down snug to thefacet joint. Bone fastener 108 may then be backed off about a quarter ofa turn. Backing the fastener off about a quarter of a turn may allow forfull motion of collar 112 relative to bone fastener 108. FIG. 67Bdepicts driver 292 after bone fastener 108 has been advanced to thedesired depth. After bone fastener 108 has been advanced to the desireddepth, driver 292 may be removed from the head of bone fastener 108 andfrom dilator 302. FIG. 67C depicts dilator 302 and sleeve 244 afterremoval of driver 292. After removal of driver 292, dilator 302 may beremoved from the patient. FIG. 67D depicts collar 112 of bone fastenerassembly 102 and sleeve 244 after removal of dilator 302.

After boric fastener 108 has been secured to the vertebra and driver 292has been removed from sleeve 244, the polyaxial nature of collar 112 mayallow angulation of sleeve 244 relative to bone fastener 108. Tissuesurrounding the incision may be released such that sleeve 244 is angledtoward a central location between vertebrae to be stabilized. Sleeve 244may be moved to facilitate positioning of instruments and/or tofacilitate access to the adjacent vertebra that is to be stabilized. Forexample, sleeve 244 may be tilted towards the adjacent pedicle so thatadditional length of an opening in the patient is not needed. Thechannel in sleeve 244 may be turned toward the adjacent pedicle that isto be stabilized with the spinal stabilization system being formed.

A plane of dilated tissue may be created between a first pedicle and asecond pedicle to be stabilized with a spinal stabilization system. Bonefastener assembly 102 and sleeve 244 may be coupled to the firstpedicle. The second pedicle may be adjacent to the first pedicle. In oneembodiment, a tissue wedge may be placed in sleeve 244 coupled to thefirst pedicle such that the distal end of the tissue wedge contacts thehead of bone fastener 108. The proximal end of sleeve 244 coupled to thefirst pedicle may be held such that tissue around the incision is notpulled or stretched. The tissue wedge may be warded through the channelin sleeve 244 and the slot in collar 112 toward the target location atthe second pedicle, thereby creating a plane in muscle and other tissuebetween the head of the installed bone fastener 108 and the targetlocation of a second bone fastener 108. In some embodiments, a tissuewedge may be pivoted about an inside proximal edge of sleeve 244 suchthat the distal end of the tissue wedge bluntly splits the muscle andfascia along fibers and create a tissue plane between the two pedicles.The wanding action may be repeated more than once (e.g., two or threetimes) to create a good working plane and displace unwanted tissue fromthe plane. The wanding may create a tissue plane. In some embodiments,the tissue plane may be substantially trapezoidal. In certainembodiments, a tissue plane may be created before bone fastener assembly102 is inserted into a vertebra,

FIGS. 68A-D depict some stages during use of a tissue wedge to form atissue plane between sleeve 244 in a first pedicle and a target locationat a second pedicle. FIG. 68A depicts tissue wedge 308 aligned abovepedicle 164A in sleeve 244. With a portion of tissue wedge 308 heldproximate to the proximal end of sleeve 244 or resting on the proximalend of sleeve 244, blade 312 of tissue wedge 308 may be moved throughsoft tissue from pedicle 164A toward pedicle 164B. FIG. 68B depictsdistal end of tissue wedge 308 positioned at pedicle 164B. After tissuewedge 308 contacts pedicle 164B, handle 310 may be moved toward pedicle164B (i.e., away from sleeve 244) to further separate soft tissue in aplane between the pedicles. FIG. 68C depicts tissue wedge 308 alterhandle 310 has been angled away from sleeve 244. An initial plane may becreated by wanding tissue wedge from pedicle 164A to pedicle 164B.Tissue wedge 308 may be similarly wanded back to pedicle 164A to furtherestablish the plane. FIG. 68D depicts tissue wedge 308 realigned insleeve 244 after the plane has been established with a back-and-forthmotion. In some embodiments, handle 310 may be maintained proximatesleeve 244 to minimize the area of the tissue plane.

A tissue plane may be made in a variety of shapes including, but notlimited to, substantially trapezoidal, substantially rhomboidal, andsubstantially triangular. A tissue plane with a substantially geometricshape may have the basic geometric shape with, for example, slightlycurved edges and/or slightly rounded corners or apices. In someembodiments, sleeve 244 length may be chosen to reduce a size of atissue plane that needs to be formed between pedicles. In certainembodiments, creating a trapezoidal tissue plane may reduce theinvasiveness of a procedure. Limiting the area of the plane may promotea faster recovery time and/or may reduce an amount of post-operativepain experienced by the patient.

In one embodiment, a tissue wedge may be coupled to a portion of sleeve244 to facilitate creation of a tissue plane. FIG. 69 depicts tissuewedge 308 with blade 312 pivotally coupled to a proximal extension ofsleeve 244. Tissue wedge 308 may be initially positioned in sleeve 244with a distal end of blade 312 proximate pedicle 164A. Handle 310 may bepivoted toward pedicle 164A to allow wanding of blade 312 towardsadjacent pedicle 164B. If needed, cutting edge 318 may be used to severfascia that inhibits passage of blade 312. Sleeve 244 may be pivoted inconjunction with rotation of collar 112. In another embodiment, sleeve244 may be extendable (e.g., telescopic) such that a pivot point may beadvanced in the direction of pedicle 164B during wanding. The extendableportion of sleeve 244 may be selectively lockable using a variety oflocking mechanisms including, but not limited to, a setscrew, a clip, adetest, or a pin.

In one embodiment, two pedicles may be targeted and bone fastenerassemblies anchored in both pedicles before creation of a tissue plane.A tissue wedge may be inserted at either of the pedicles. In someembodiments, sleeves 244 may be coupled to each other at proximal endsof sleeves 244. The tissue wedge may be coupled to sleeve 244 and sleeve244 may be used as an anchor during wending. Insertion of elongatedmember 104 into collars 112 of bone fastener assemblies 102, however,may require cutting of some tissue between sleeves 244.

Other procedures may be used to create a tissue plane. For example,before targeting pedicle locations (i.e., before bone fastenerinsertion), a tissue wedge may be worked downward from an incision tocreate a tissue plane. Alternatively, a scalpel may be used to cut fromthe surface of the body to vertebral bone. Extensive use of a scalpel,however, may remove benefits of a minimally invasive procedure.

In one embodiment, a targeting needle may be passed through the tissueto create a tissue plane for insertion of an elongated member. Asdepicted in FIG. 70A, targeting needle 198 may be placed in sleeve 244Acoupled to pedicle 164A. Sleeve 244A may be rotated such that channel248 is directed toward pedicle 164B. In some embodiments, a handleportion of targeting needle 198 may be positioned over pedicle 164B, asdepicted in FIG. 70B. The shaft of targeting needle 198 may be wandedfrom sleeve 244A (e.g., from a center of sleeve 244A) in pedicle 164A toa target location in pedicle 164B to separate the soft tissue in a planebetween the pedicles. FIG. 70C depicts a distal end of targeting needle198 positioned proximate pedicle 164B. Targeting needle 198 may be movedback and forth to establish the plane. After targeting needle 198contacts pedicle 164B and the plane is established, bone fastenerassembly 102 may be inserted in pedicle 164B using a procedure similarto the procedure used to place bone fastener assembly 102 in an adjacentpedicle. FIG. 70D depicts sleeves 244A and 244B located proximatepedicles 164A and 164B, respectively.

Once a well-defined tissue plane has been formed, a targeting needle maybe passed down a first sleeve coupled to a first vertebra and thenwended along the formed plane over to a target location at a secondpedicle. The target location at the second pedicle may befluoroscopically confirmed. Bone fastener assembly 102 coupled to sleeve244 may be secured in the second pedicle using a procedure similar tothe procedure used to insert bone fastener assembly 102 in a firstpedicle. FIG. 71 depicts substantially trapezoidal tissue plane 378between sleeves 244 coupled to adjacent vertebral bodies 166. Sleeves244 touch at incision 375 and cross above body surface 376, such that alength of the incision and/or an area of tissue plane 378 may beadvantageously small. Substantially trapezoidal tissue plane 378 mayhave a dimension at body surface 376 equal to a length of the incision.Sides of substantially trapezoidal tissue plane 378 may be defined bysurfaces of sleeves 244. Opposite the body surface 376, substantiallytrapezoidal tissue plane 378 may extend between collars 112. In someembodiments, the edge of substantially trapezoidal tissue plane 378closest vertebral bodies 166 may be substantially straight. In someembodiments, the edge of substantially trapezoidal tissue plane 378closest vertebral bodies 166 may be curved to match a contour of bonebetween the vertebral bodies.

With bone fastener assemblies secured in the vertebral bodies, sleeves244 coupled to bone fastener assemblies 102 may be oriented tofacilitate insertion of elongated member 104 in sleeves 244. In someembodiments, sleeves 244 may serve as tissue retractors during a spinalstabilization procedure. Angular motion of collar 112 may be limited bya range of motion allowed between collar 112 and bone fastener 108 thatcollar 112 is anchored to. Angular motion of collar 112 may be limitedby patient anatomy. Angular motion or orientation of one collar (i.e.,sleeve), however, may not depend upon a position of another collar(i.e., sleeve). In some embodiments, channel openings in sleeves 244 mayface each other. In some embodiments, channel openings in sleeves 244may be angled relative to each other in various arrangements. A distancebetween sleeves 244 may be estimated using an estimating tool. Thedistance between sleeves 244 may be used to select a length of elongatedmember 104 needed to couple collars 112,

In one embodiment, flexible arms of estimating tool 320 depicted in FIG.54 may be positioned in sleeves 244. With the activator disengaged, theestimating tool may be advanced toward the pedicles until the arms ormembers rest on collars 112 or bone fasteners 108 of bone fastenerassemblies 102. The activator may be engaged. When the arms arewithdrawn from sleeves 244, a biasing element may allow the arms toextend to the length indicative of the distance between bone fastenerassemblies 102. Elongated member 104 length may be selected by measuringa distance between the members of the estimating tool. The measureddistance may be increased by an amount to allow elongated member 104 toextend beyond collars 112 after curvature and/or insertion. In oneembodiment, about 5 mm to about 30 mm (e.g., about 15 mm) may be addedto the measured distance. In some embodiments, a desired length ofelongated member 104 may be a length that allows elongated member 104 toextend from each collar 112 by about 2 mm or about 3 mm. In certainembodiments, ends of elongated member 104 may be flush with the outersurface of one or more collars 112.

In one embodiment, elongated member 104 of desired length may be chosenby estimating a distance between sleeves 244 without the use of anestimating tool. Sleeves 244 may be positioned as desired (e.g.,substantially parallel to each other). A distance between the mostdistant outer edges of sleeves 244 may be estimated. The estimateddistance may be increased by an amount to allow elongated member 104 toextend beyond collars 112 after insertion. In some embodiments, fromabout 1 mm to about 20 mm may be added to the estimated distance. Insome embodiments, a desired length of elongated member may be a lengththat allows elongated member 104 to extend from each collar 112 by about2 mm,

Elongated member 104 may be cut to length and contoured as desired. Forexample, a medical practitioner may use experience and judgment todetermine curvature of elongated member 104 for a patient. A desiredcurvature for elongated member 104 may be determined using fluoroscopicimaging. In some embodiments, a curvature of elongated member 104 may bechosen such that, when elongated member 104 is secured to collars 112 ofbone fastener assemblies 102, sleeves coupled to bone fastenerassemblies 102 cross at a surface of the skin. Crossing of sleeves 244at a surface of the skin allows the medical practitioner to minimizetrauma to a patient by minimizing incision length and tissue plane area.Elongated member 104 may be bent or shaped with a tool (e.g., a rodbender) to allow insertion of elongated member 104 through channels ofsleeves 244 with various spatial locations and/or various angularorientations.

Elongated members 104 may have shapes including, but not limited to,straight, bent, curved, s-shaped, and z-shaped. FIG. 72 depicts oneembodiment of S-shaped elongated member 104. FIG. 73 depicts oneembodiment of angled elongated member 104. FIG. 74 depicts oneembodiment of bent elongated member 104. FIG. 75 depicts one embodimentof straight elongated member 104. In some embodiments, elongated members104 may have a substantially circular longitudinal cross section. Incertain embodiments, elongated members 104 may have othercross-sectional shapes including, but not limited to, regular shapes(oval, rectangular, rhomboidal, square) and irregular shapes. Aninstrumentation kit for a spinal stabilization system may includestraight rods and/or pre-shaped rods. Straight rods and/or pre-shapedrods may be contoured to accommodate patient anatomy if needed duringthe surgical procedure.

Channels of sleeves 244 and slots of collars 112 may be oriented byrotating sleeves 244 to accommodate insertion and seating of theelongated member. In certain embodiments, a channel opening in sleeve244 may be non-linear (e.g., bent, curved, or angled) to allow portionsof the spine to be selectively stabilized. Sleeve orientation and/ordesign may be chosen to allow compression, distraction, and/or reductionof vertebrae. In some embodiments, there may be no constraints governingrelative location and/or orientation of sleeves 244. Sleeves 244 may beforced apart or angled toward each other or away from each other toaccommodate insertion of the elongated member.

Prior to insertion of the elongated member, the tissue wedge ortargeting needle may be used to wand between bone fasteners 108 toensure a clean plane between bone fasteners 108. An end of elongatedmember 104 may be inserted at an angle or substantially longitudinallyin a passage and/or channel of sleeve 244 coupled to bone fastenerassembly 102. Inserting elongated member 104 at an angle orsubstantially longitudinally allows the length of the incision and/orthe area of the tissue plane to remain advantageously small. In someembodiments, sleeves coupled to anchored bone fastener assemblies 102may remain essentially unconstrained relative to each other duringinsertion of elongated member 104. In certain embodiments, angularorientation of collars 112 may determine a trajectory of elongatedmember 104 down sleeves 244 and into collars 112 of bone fastenerassemblies 102. Inserting elongated member 104 down two or more sleeves244 and through an open path (i.e., the tissue plane) may allow amedical practitioner to avoid surgical difficulties associated withanatomical abnormalities and/or misalignment of system components (e.g.,in multi-level stabilization procedures).

Insertion of elongated member 104 may not be visualized subcutaneously.Therefore, positioning tool 334 may be used to guide elongated member104 down sleeves 244 into slots in collars 112. A distal portion ofpositioning tool 334 may be contoured. The contour may allow for somerotation of elongated member 104. With slight pressure, elongated member104 may be rotated subcutaneously into a substantially horizontalposition and seated in collars 112. Positioning tool 334 may be heldfirmly while still allowing a rocking movement between elongated member104 and the distal end of positioning tool 334. Movement of elongatedmember 104 may allow elongated member 104 to be maneuvered down sleeves244 and into collars 112.

FIG. 76A depicts insertion of a first end of elongated member 104 in anopening of channel 248A of sleeve 244A. In one embodiment, elongatedmember 104 may be positioned between grasping member 342 and distal end344 of the inner shaft of positioning tool 334, as shown in FIG. 76B.Elongated member 104 may be held between grasping member 342 and distalend 344 of the inner shaft of positioning tool 334 with pressure appliedto a proximal end of the inner shaft. As the first end of elongatedmember 104 is moved along the length of sleeve 244A toward collar 112A,a second end of elongated member 104 may be inserted in channel 248B ofsleeve 244B. Channels in sleeves 244A and 244B may include groovesopposite channel openings to engage ends of elongated member 104 and/orto guide elongated member 104 along the lengths of sleeves 244.Positioning tool 334 may be used to guide elongated member 104 along thelength of sleeves 244 through the plane in the soft tissue.

Slots in collars 112A, 112B may be aligned with channels 248A, 248B ofsleeves 244A, 244B, respectively, to allow elongated member 104 to bepositioned in collars 112. Positioning tool 334 may be used to angleelongated member 104 through slot 150A such that an end of elongatedmember 104 protrudes through collar 112A away from collar 112B. With oneend of elongated member 104 extending through slot 150A in collar 112A,positioning tool 334 may be used to guide the other end of elongatedmember 104 the remaining distance down second sleeve 244B. Positioningtool 334 may then be used to seat the second end of elongated member 104in collar 112B and translate elongated member 104 to a desired locationrelative to collars 112. The distal end of the positioning tool innershaft may be contoured (e.g., curved and/or grooved) to allow somemotion (e.g., rocking) of elongated member 104 while elongated member104 is coaxed into position and/or rotated subcutaneously with thepositioning tool. Pressure may be applied to inner shaft 340 to seatelongated member 104 in the slots of collars 112. FIG. 76C depictselongated member 104 seated in collars 112A, 112B,

In some embodiments, a seater may be used to seat elongated member 104in collars 112.

FIG. 76D depicts seater 348 positioned in sleeve 244B. In certainembodiments, seater 348 may be used to push elongated member 104 intoslots in collar 112A and/or 112E while positioning tool 334 is used tomaneuver elongated member 104 into place. Once elongated member 104 ispositioned in collars 112, fluoroscopic confirmation may ensure thatelongated member 104 is inserted fully into each collar. Prior tosecuring elongated member 104 to bone fastener assemblies 102 withclosure members 106, elongated member 104 may be gripped firmly withpositioning tool 334 and persuaded cephalad or caudad as needed. Withelongated member 104 seated in collars 112, orientation of sleeves 244may be constrained relative to each other.

After elongated member 104 is seated in collars 112, additionalfluoroscopic confirmation of elongated member positioning may beobtained. With elongated member 104 satisfactorily positioned, elongatedmember 104 may be secured in place with closure members 106. FIG. 60Adepicts closure member 106 coupled to driver 354. Driver 354 ispositioned for insertion into sleeve 244. A counter torque wrench may becoupled to sleeve 244 or to elongated member 104. After insertion ofdriver 354 in sleeve 244, closure member 106 may be positioned proximatecollar 112. With driver 354 positioned in sleeve 244, as shown in FIG.60B, driver 354 may be rotated to advance closure member 106 in collar112. To ensure alignment of thread of closure member with thread ofcollar, the driver may initially be rotated in a direction that wouldresult in removal of closure member 106 from collar 112. When the userof the driver feels engagement of threading of closure member 106 withthreading of collar 112, the user may reverse the direction of rotationof driver 354 to secure closure member 106 to the driver. Closure member106 may secure elongated member 104 to collar 112. Sleeve 244A may serveas a coaxial guide to inhibit cross-threading during insertion ofclosure members 106. When closure members 106 are snug and elongatedmember 104 is secured, collars 112 are angled such that slots in collars112 are substantially perpendicular to the elongated member. Driver 354may be disengaged from closure member 106 and removed from sleeve 244.In some embodiments, driver 354 may be used to shear off tool portion170 of secured closure member 170. In certain embodiments, a couplingportion of driver 354 may capture a sheared tool portion 170 fromclosure member 106.

Torque required to shear off tool portion 170 of closure member 106 maybe a source of pain and/or injury to a patient. In some embodiments,sleeve 244 may be held with a counter torque wrench 364 or 368 as toolportion 170 of secured closure member 170 is sheared off. In oneembodiment, about 90 in-lbs of torque may be required to shear off toolportion 170 of closure member 106. A counter torque wrench may inhibitor reduce transfer of torque to the patient's spine. FIG. 61 depicts oneembodiment of counter torque wrench 364 used above the skin to inhibitapplication of torque to a patient's spine during shearing of a toolportion of secured closure member 106. Sleeve 244 may fit in opening 366of counter torque wrench 364. Counter torque wrench 364 may bepositioned near a proximal end of sleeve 244 during use.

Force may be applied to counter torque wrench 364 in a directionopposite to rotational force applied to driver 354 to shear off toolportion 170 of closure member 106. Thus, tool portion 170 of closuremember 106 may be sheared off with force exerted above the incision of apatient. In some embodiments, collar 112 of bone fastener assembly 102may be designed such that a proximal portion of collar 112 may besheared off with force exerted above the incision of a patient. In someembodiments, closure member 106 may be designed (e.g., with a solidcentral core) such that the torque required to shear off tool portion170 does not adversely affect the body of closure member 106 or thecoupling between closure member 106 and collar 112. Opening 366 intorque wrench 364 may be of any shape to accommodate a cross-sectionalshape of sleeve 244.

In some embodiments, counter torque wrench 368 shown in FIG. 63 may beused to inhibit application of torque to a patient's spine. Countertorque wrench sleeve 370 may be inserted through the opening in the bodyover sleeve 244. Counter torque wrench sleeve 370 may be advanced towardthe spine until elongated member 104 is seated in groove 374 of thecounter torque wrench sleeve. Force may be applied to counter torquewrench 368 in a direction opposite to rotational force applied to adriver used to shear off a tool portion of a secured closure member.

Coupling failure between collar 112 and closure member 106 of bonefastener assembly 102 may be a concern during surgery. If failure occurswhile locking down elongated member 104 to bone fastener assembly 102 ina single- or multi-level system, the failure may require removal of oneor more locked closure members and elongated member 104 to extract afailed bone fastener assembly. Coupling failure may occur duringapplication of other loads, such as loads used to achieve reduction witha spinal stabilization system.

FIG. 77 depicts a distal portion of driver 380 that may be used toremove closure member 106 depicted in FIGS. 14 and 15. A distal end ofdriver 380 may include two prongs designed to fit in removal openings174 of closure member 106. Driver 380 may be inserted in sleeve 244 toengage closure member 106. A handle of driver 380 may allow a medicalpractitioner to apply force in a rotational direction necessary toremove closure member 106. In some embodiments, a counter torque wrenchmay be used to inhibit application of torque to the patient's spineduring removal of closure member 106. Closure member 106 may be removedand replaced as necessary.

After closure member 106 is successfully secured to collar 112 and atool portion of closure member 106 has been sheared off, the driver maybe removed from sleeve 244 coupled to the anchored bone fastenerassembly. FIG. 78A depicts an assembled spinal stabilization systemfollowing removal of driver 354. Key 262, shown in FIG. 78B, may be usedto rotate movable members in sleeves 244A, 244B. Rotation of movablemembers in sleeves 244A, 244B may release the movable members fromcollars 112. Thus, sleeves 244A, 244B may be uncoupled from collars 112above the incision. FIG. 78C depicts assembled spinal stabilizationsystem 100 following removal of sleeve 244A. FIG. 78D depicts assembledspinal stabilization system 100 coupled to adjacent pedicles followingremoval of sleeve 244B.

A spinal stabilization system may be used to stabilize two or morevertebral levels (i.e., at least three adjacent vertebrae). In oneembodiment, an incision may be made in the skin between the outermostvertebrae to be stabilized. A first bone fastener assembly 102 may becoupled to a first sleeve 244. First bone fastener 108 may be threadedinto a first pedicle at a target location such that first sleeve 244extends above the body surface. First sleeve 244 may rotate about thehead of first bone fastener 108. A tissue plane may be created between achannel opening in first sleeve 244 and a target location at a secondpedicle. In one embodiment, the second pedicle may be adjacent to thefirst pedicle. A second bone fastener assembly 102 may be coupled tosecond sleeve 244 and threaded into the second pedicle through theincision. Another tissue plane may be created between first sleeve 244or second sleeve 244 and a target location in a third pedicle. The thirdpedicle may be adjacent to the first pedicle and/or the second pedicle.A third bone fastener assembly 102 may be coupled to third sleeve 244and threaded into the third pedicle through the incision.

In one embodiment of a method for a two-level spinal stabilizationprocedure, an incision may be made above a target location in a middlepedicle. A first bone fastener 108 may be anchored to the middlepedicle. After first bone fastener 108 is secured, second and third bonefasteners 108 may be coupled to outer pedicles as desired by pullingand/or stretching tissue surrounding the incision to allow access to theouter pedicles.

Channel openings in sleeves coupled to three bone fastener assemblies102 may be oriented to allow insertion of elongated member 104 toachieve two-level spinal stabilization. FIGS. 79A-79E depict insertionand seating of elongated member 104 in a two-level spinal stabilizationsystem. Use of a elongated member positioner 334 and/or seater isimplied but not shown in FIGS. 79A-79E. FIG. 79A depicts insertion of afirst portion of elongated member 104 through channel 248′ ofmulti-channel sleeve 244 and into channel 248 of sleeve 244B. As thefirst portion of elongated member 104 is moved down the length ofchannels 248, 248′ toward collars 112, 112′, a second portion ofelongated member 104 may be inserted in channel 248 of sleeve 244A. Insome embodiments, elongated member 104 may be moved down channels 248,248′ using a positioning tool. As elongated member 104 is advancedtoward collars 112, 112′, elongated member 104 may pass through anopening in the skin and into the tissue plane. FIG. 79B depictselongated member 104 in channels 248, 248′. Channels 248 in sleeves244A, 244B may include grooves to engage ends of elongated member 104and/or to guide elongated member 104 down the lengths of sleeves 244. Incertain embodiments, channel openings may be curved or angled toaccommodate various elongated member configurations.

FIG. 79C depicts elongated member 104 engaged in channels 248, 248′. Aselongated member 104 is advanced toward collars 112, 112′, a first endof elongated member 104 may emerge through slot 150 in collar 112coupled to sleeve 244B. FIG. 79D depicts elongated member 104 afterelongated member 104 has emerged through slot 150 in collar 112 coupledto sleeve 244B. In some embodiments, a seater may be used to positionelongated member 104 in collars 112, 112′. FIG. 79E depicts elongatedmember 104 seated in collars 112, 112′.

FIGS. 80A-80C depict perspective views of various orientations sleeves244 may assume relative to bone fasteners 108, 108′. In two-level andmulti-level spinal stabilization systems, an orientation of sleeve 244coupled to an anchored bone fastener assembly 102 is not constrained byan orientation of one or more other collars 112 coupled to adjacent bonefastener assemblies 102. FIGS. 80A-80C also depict various orientationsthat bone fasteners 108, 108′ may assume relative to each other. Bonefasteners 108, 108′ may be offset from each other (i.e., non-planar)and/or be inserted in pedicles at opposing angles. The range of possibleorientations of bone fasteners 108 in pedicles may allow a spinalstabilization system to securely conform to a patient's spine.

After elongated member 104 has been positioned and seated in collars 112as desired, closure members 106 may be used to secure elongated member104 to collars 112. One or more counter torque wrenches 364 or 368 maybe used during shearing of tool portions 170 of closure members 106. Inone embodiment, counter torque wrench 364, depicted in FIG. 61, may beused with sleeves 244A, 244B. Counter torque wrench 368, depicted inFIG. 62, may be used with multi-channel sleeves and/or single-channelsleeves.

In certain embodiments, an external frame may be used to impose adesired constraint on one or more sleeves. For example, an externalframe may hold one or more sleeves in a particular location and/ororientation such that a desired relative positioning of vertebrae may beachieved. An external frame may be used to impose a distance and/orangle between sleeves to achieve distraction or compression ofvertebrae. Reduction of vertebrae may be achieved when an external frameis used to adjust a relative height of sleeves 244.

In some embodiments, a spinal stabilization system may be inserted usingan invasive procedure. Since insertion of a spinal stabilization systemin an invasive procedure may be visualized, cannulated components (e.g.,bone fasteners) and/or instruments (e.g., detachable members) may not beneeded for the invasive (i.e., open) procedure. Thus, a bone fastenerused in an invasive procedure may differ from a bone fastener used in aminimally invasive procedure. FIG. 81 depicts a perspective view of anembodiment of bone fastener 108 that may be used in an invasiveprocedure.

Bone fastener 108 may include shank 116, head 118, and neck 120. Shank116 may include threading 122. In some embodiments, threading 122 mayinclude self-tapping start 124. Self-tapping start 124 may facilitateinsertion of bone fastener 108 into vertebral bone. Head 118 of bonefastener 108 may include various configurations to engage a driver thatinserts the bone fastener into a vertebra. In certain embodiments, thedriver may also be used to remove an installed bone fastener from avertebra.

In some embodiments, head 118 may include one or more tool portions 126.Tool portions 126 may be recesses and/or protrusions designed to engagea portion of the driver. Driver 380 depicted in FIG. 77 may be used toengage bone fastener 108 with tool portions 126 as depicted in FIG. 81.Head 118 of bone fastener 108 may include one or more splines. In someembodiments, bone fastener 108 may be used with a collar, a ring, and/ora closure member described for use with a cannulated bone fastener. Incertain embodiments, bone fasteners with closed collars may be used inan invasive spinal stabilization procedure. In certain embodiments,fixed bone fasteners (e.g., open fixed bone fasteners) may be used in aninvasive spinal stabilization procedure.

In some embodiments, tools used in an invasive procedure may be similarto tools used in a minimally invasive procedure. In certain embodiments,methods of installing a spinal stabilization system in an invasiveprocedure may be similar to methods of installing a spinal stabilizationsystem in a minimally invasive procedure.

In some embodiments, spine stabilization may have one or morecross-links implanted to provide additional support or stabilization.FIGS. 82-94 depict embodiments of cross-links 400 that are particularlyuseful for providing additional support to spinal stabilization systemssuch as described above.

In some embodiments cross-links 400 may provide additional rigidity tospinal stabilization systems. The additional rigidity may help reduce,limit, or eliminate undesired motions or stresses. In one embodimentcross-link 400 may limit or eliminate torsional movements in theaffected levels of the spine, may provide torsional stability to thespine, and may facilitate fusion in one or more desired levels.

Cross-link devices 400 according to embodiments of the presentdisclosure provide the surgeon with more options for stabilizing thespine, and help achieve a better fit among the various parts of thesystem. Viewed another way, by providing variable length cross-linkingor coupling between elongated members 104, cross-link 400 more readilyconform to the geometry and shape of elongated members 104 and theanatomy of the spine. Embodiments of the present disclosure may providesupport and stabilization of the spine. Accordingly, a surgeon need notcontour the cross-link devices and/or the rods in order to fit animplant to a particular patient's anatomy. By conforming to thepatient's anatomy, spinal stabilization systems according to embodimentsof the present disclosure may provide better support and immobilizationof the spine, thus may accelerate the healing or fusion processes. Incontrast, in a typical implant procedure the surgeon generally formselongated members 104 to conform them to the patient's anatomy, i.e.,the physical properties and geometry of the spine.

Another advantage over prior art approaches to cross-linking elongatedmembers 104 is the reduced number of fasteners needed by embodiments ofthe present disclosure. Conventional approaches often involvepositioning and fastening a relatively large number of fasteners inorder to situate the cross-link devices as part of the implant. Asdescribed below in detail, the variable length cross-link devicesaccording to embodiments of the present disclosure, however, enablesurgeons to couple portions of a cross-link device in order to couple toelongated members 104.

In some embodiments, cross-link 400 may be inserted into a body usingMIS procedures. In some embodiments, one or more portions of cross-link400 may be connected to a tool useful for advancing cross-link 400 intothe body. In some embodiments, a portion of cross-link 400 may connectedto a detachable member such as sleeve 244 and advanced into the bodyusing sleeve 244. In some embodiments, a portion of one embodiment ofcross-link 400 may be connected to a guide wire such as guide wire 218and advanced into the body. FIGS. 82-87 depict embodiments of cross-link400 that may be implantable using MIS procedures,

FIG. 82A depicts a perspective view of a portion of a spinalstabilization system that may include cross-link device 400 according toan illustrative embodiment of the disclosure, and FIG. 82B depicts aclose-up side view of a portion of the embodiment. In one embodiment,cross-link 400 may connect to elongated members 104 at one or morelocations, as desired. In one embodiment, a surgeon may use cross-linkdevices 400 at one or more desired locations to further support andimmobilize the spine.

In one embodiment, fixed portion 402 may connect to elongated member104, and couple to adjustable portion 404 that may be connected toelongated member 104. In some embodiments, engaging member 408 connectsreceiver portion 406 of fixed portion 402 to elongated member 104. Insome embodiments engaging member 408 may have helically wound thread412. In some embodiments engaging member 408 may include one or moretool portions 414 for detachable connection to a driver. In someembodiments engaging member 408 may be configured to shear off a portiononce a selected torque level has been achieved. In some embodiments,engaging member may include one or more tool portions 422 configured toenable engaging member 408 to be removed even if a portion has beensheared off during implantation. In some embodiments, closure member 106described in FIG. 14 may be used as engaging member 408. In someembodiments, engaging member 408 may have a thread form similar to thethread forms described in relation to FIGS. 17A, 17B, 18A, and 18B. Inother words, some embodiments may advantageously use closure members 106of existing spine stabilization systems to connect receiver portion 406of fixed portion 402 to elongated member 104.

In some embodiments fixed portion 402 may include transverse portion410. Transverse portion 410 may have any length necessary to spanbetween elongated members 104. For example, transverse portion 410 mayhave a shorter length for spanning between elongated members 104 in thecervical region of the spine as compared with the lumbar region. In someembodiments, transverse portion 410 may have a length sufficient toextend some distance beyond adjustable portion 404. In some embodiments,the distance between elongated members 104 may be controlled byconnecting a tool to the end of transverse portion 410 and advancingtransverse portion 410 a selected distance through adjustable portion404. In some embodiments, transverse portion 410 may have a generallycontinuous surface. In some embodiments, a cross-section of transverseportion 410 may be circular, oval, square, hexagonal, or some othercurved or angled profile.

In some embodiments cross-link 400 may include adjustable portion 404for connection to elongated member 104 and coupling to transverseportion 410. In some embodiments, adjustable portion 404 may includeflange 426. In some embodiments, flange 426 may be configured fordetachable connection with one embodiment of sleeve 244 depicted abovein FIGS. 26-43. For example, notches 428 in adjustable portion 404 mayaccommodate end of movable member 252 depicted in FIG. 31. In someembodiments, sleeve 244 may connect to adjustable portion 404 usingmethods described for connecting sleeve 244 to collar 112. In otherwords, some embodiments enable surgeons to use the same instrumentationto connect adjustable portion 404 to elongated member 104 that they useto insert closure member 106 in collar 112. Advantageously, using thesame instrumentation for multiple steps in a surgical procedure mayresult in improved familiarity of the instruments by the surgeon forbetter surgical results, as well as lower costs.

In some embodiments adjustable portion 404 may be configured forconnection to elongated member 104. In some embodiments, adjustableportion 404 may include connection member 424 for connecting adjustableportion 404 to elongated member 104. In some embodiments, applying adownward pressure on connection member 424 may maintain adjustableportion 404 connected to elongated member 104.

In some embodiments adjustable portion 404 may be configured forcoupling with transverse portion 410. In some embodiments, adjustableportion 404 may include transverse portion engaging member 416 forcoupling to transverse portion 410. In some embodiments transverseportion engaging member 416 may include helically wound thread 418. Insome embodiments engaging member 416 may include one or more toolportions 432 for detachable connection to a driver. Driver 354 depictedin FIG. 59A is an example of a driver that may be useful for engagingone or more tool portions 432 on transverse portion engaging member 416.In some embodiments transverse portion engaging member 416 may beconfigured to shear off once a selected torque level has been achieved.In some embodiments, closure member 106 described in FIG. 14 may be usedas transverse portion engaging member 416. In other words, someembodiments may advantageously use closure members 106 of existing spinestabilization systems to connect adjustable portion 404 to transverseportion 410.

In some embodiments, coupling adjustable portion 404 to transverseportion 410 may further connect adjustable portion 404 to elongatedmember 104. In some embodiments, threading transverse portion engagingmember 416 to couple adjustable portion 404 to transverse portion 410may further compress transverse portion 410 onto connection member 424such that connection member 424 compresses onto elongated member 104.

FIG. 83 depicts a perspective view of an embodiment of cross-link 400connected to elongated members 104. In some embodiments, fixed portion402 may not include engaging member 408 as depicted in FIG. 82, whichadvantageously reduces the number of fasteners required by embodiments.In some embodiments, fixed portion 402 may be configured for connectingto elongated member 104 using a compression fit, sweat-lock fit, or thelike. In some embodiments, transverse portion 410 and receiver portion406 may have a cannulated passage 450 for inserting a guide wire toadvance fixed portion 402 into the body. In some embodiments, guide wire218 depicted in FIGS. 22 and 23 may have sufficient strength, diameter,and flexibility to advance in an incision in the body to an orientationnear elongated member 104 such that fixed portion 402 may be advancedinto the body.

In some embodiments, transverse portion 410 may have selected length toadvance through adjustable portion 404 such that a tool may connect tothe end of transverse portion 410. In some embodiments, the distancebetween elongated members 104 may be controlled by advancing transverseportion 410 through adjustable portion 404 and coupling transverseportion 410 to adjustable portion 404. In some embodiments, transverseportion 410 may include one or more engagement features 442 for couplingtransverse portion 410 to adjustable portion 404. In some embodiments,transverse portion 410 may have a series of notches 442. In someembodiments, notches 442 may extend the length of transverse portion 410or may extend only a portion. In some embodiments, engagement features442 may circumscribe transverse portion 410 or may define an arc lengththereof. In one embodiment, transverse portion 410 may include a seriesof notches 442 for engagement by a pawl, ratchet or extension inadjustable portion 404 to couple with transverse portion 410.

In some embodiments, connection member 424 may connect adjustableportion 404 with elongated member 104. In some embodiments, connectionmember 424 may be offset from transverse portion 410 such that each maybe employed independent of the other during surgery. In someembodiments, connection member 424 may include a helically wound threadfor rotatable advancement in adjustable portion 404 such that adjustableportion 404 may be connected to elongated member 104 independent ofadjustable portion 404 coupling to transverse portion 410.Advantageously, this independence may allow embodiments of cross-link400 to be implanted by first connecting adjustable portion 404 toelongated member 104 and then coupling adjustable portion 404 to fixedportion 402 or vice versa.

In some embodiments, adjustable portion 404 may include one or morecannulated passages 450 for insertion of a guide wire useful foradvancing adjustable portion 404 into the body. In some embodiments,guide wire 218 depicted in FIGS. 22 and 23 may have sufficient strength,diameter, and flexibility to advance in an incision in the body to anorientation near elongated member 104 such that adjustable portion 404may be advanced into the body.

In some embodiments, cross-link 400 may provide stability betweenelongated members 104 without fasteners. FIG. 84 depicts one embodimentof cross-link 400 that may include fixed portion 402 with receiver 406and transverse portion 410 coupled to adjustable portion 404, havingonly transverse portion engaging member 416 (not visible). In someembodiments, receiver portion 406 may connect to elongated member 104(not shown) using a compression fit such that engaging member 408 (suchas depicted in FIG. 82) may not be necessary. In some embodiments,adjustable portion 404 may connect to elongated member 104 (not shown)using a compression fit such that connection member 424 (such asdepicted in FIG. 82) may not be necessary. In some embodiments,transverse portion 410 may include a series of notches 442 forengagement by adjustable portion 404 to couple adjustable portion 404with fixed portion 402.

FIG. 85A depicts a diagrammatic side view of one embodiment ofcross-link device 400, and FIG. 85B depicts a diagrammatic end view ofthe same embodiment. In one embodiment, cross-link 400 may have agenerally biased configuration (i.e., receiver portion 406 of fixedportion 402 and adjustable portion 404 may be oriented facing the samedirection). A biased configuration may ensure elongated members 104 maybe prevented or hindered from moving in a desired direction onceimplanted in the body. In one embodiment, elongated members 104 mayoccupy the same horizontal plane (e.g., a plane along the spine). They,however, may have a non-parallel configuration and may diverge from eachother, converge toward each other, or remain parallel but be skewed awayfrom a desired axis. Embodiments of the present disclosure may provide aportion of the spine more freedom in one range of movement (i.e.,elongated members 104 may have more freedom on one side) but maintainrigid constraints in a second range of movement (i.e., elongated members104 may have less freedom to move in the opposite direction). As anexample, in one embodiment, the surgeon may implant biased cross-link400 on elongated members 104 in order to accommodate an injury affectingonly one side of the spine.

In one embodiment, fixed portion 402 of cross-link 400 may includereceiver portion 406 having inner surface 466 defined for connectionwith first elongated member 104. In one embodiment the connection may besufficient to prevent disconnection but allow rotation and/or movementof receiver portion 406 along elongated member 104. In one embodimentthe connection may prevent any movement or rotation of receiver portion406 relative to elongated member 104. In some embodiments, receiverportion 406 may connect to elongated member 104 due to a snap-fit, acompression fit, a sweat-locked fit, or the like.

In one embodiment, inner surface 466 of receiver portion 406 may beangular or curved to provide the desired connection with elongatedmember 104. For example, in some embodiments, inner surface 466 may bedefinable with an arc length or radius for contact with elongated member104 having a generally circular cross-sectional profile. In someembodiments, inner surface 466 may be definable by a length or width forcontact with elongated member 104 having a generally angularcross-section. In one embodiment, the configuration of inner surface 466may facilitate connection to elongated member 104 using MinimallyInvasive Surgery (MIS) techniques or in other situations in whichreceiver portion 406 may not be visible or connection of receiverportion 406 to elongated member 104 may be difficult. In one embodiment,inner surface 466 may be configured by machining, such as by knurling,grooving, bead blasting, polishing, or the like, or coated, lined, orlayered with material for connection with elongated member 104.

In some embodiments receiver portion 406 of fixed portion 402 mayinclude engaging member 408 to ensure elongated member 104 remainsconnected to fixed portion 402 once implanted in the body. In someembodiments, engaging member 408 may include a piston, spring, cam, pin,threaded member, or any combination thereof. In one embodiment, engagingmember 408 may directly engage elongated member 104, such as set screw408 threaded into passage 470 depicted in FIG. 85A. In other words, inone embodiment, set screw 408 may be threaded into passage 470 in fixedportion 402 such that the end of set screw 408 may be in direct contactwith a portion of elongated member 104. Alternatively, in oneembodiment, set screw 408 may be configured for threading into fixedportion 402 such that a portion of set screw 408 forms a barrier thatprevents fixed portion 402 from disconnecting from elongated member 104.

To enable length cross-link 400 to stabilize movement between elongatedmember 104 and elongated member 104, in one embodiment, fixed portion402 may include transverse portion 410 of selected length. In someembodiments, transverse portion 410 and receiver portion 406 may bemanufactured together as a single unit, or may be manufacturedseparately and then joined using mechanical, chemical, or thermalmethods, or some combination. For example, in some embodiments,transverse portion 410 may be threaded or compression fit to receiverportion 406. In some embodiments, transverse portion 410 may be glued orepoxied to receiver portion 406. In some embodiments, transverse portion410 may be welded or sweat-locked to receiver portion 406.

In some embodiments, transverse portion 410 may have a solid crosssection, a partially bored portion, or may have a cannulated portion. Insome embodiments, transverse portion 410 may have a curved or angularcross-section. In some embodiments, the cross-section may be symmetricor asymmetric. In some embodiments, transverse portion 410 may begenerally straight along its length or may have one or more curves,bends, or angles. In some embodiments, for example, transverse portion410 may be curved or otherwise configured to circumvent the spinousprocess or other anatomical landmark on the spine.

In some embodiments, transverse portion 410 may have one or moreengagement features along its length to facilitate coupling withadjustable portion 404. In some embodiments, transverse portion 410 mayhave a plurality of engagement features 442, such as a series of holes,indentations, notches, ribs, or teeth configured for engagement withsimilar or complementary features in adjustable portion 404. In someembodiments, engagement features 442 on transverse portion 410 may besymmetric or otherwise allow for two-way adjustment, or may beasymmetric or otherwise allow only one-way adjustment. In someembodiments, a series of indentations or notches 442 selectivelypositioned along a portion of transverse portion 410 may be configuredfor coupling with a complementary series of ribs (not shown) or a singlerib, pawl or other extension 416 on adjustable portion 404 to enablefixed portion 402 to couple with adjustable portion 404. Those skilledin the art will appreciate that the radial position of notches 442 ontransverse portion 410 may be selected based on design, manufacturing,or surgical methods. In some embodiments, notches 442 may circumscribetransverse portion 410 or may extend only about a selected radialportion of transverse portion 410.

In some embodiments, adjustable portion 404 may include inner surface464 for connecting with second elongated member 104. In one embodimentthe connection may be sufficient to prevent disconnection but allowrotation and/or movement of adjustable portion 404 along elongatedmember 104. In one embodiment the connection may prevent any movement orrotation of adjustable portion 404 along elongated member 104. In someembodiments, inner surface 464 may be angular or curved for connectingwith elongated member 104. In some embodiments, inner surface 464 may bedefined with an arc length or radius for connection with elongatedmember 104 having a generally circular cross-sectional profile. In someembodiments inner surface 464 may be defined by a length or width forconnection with elongated member 104 having a generally angularcross-section. In some embodiments, the configuration of inner surface464 may facilitate connection to elongated member 104 using MinimallyInvasive Surgery (MIS) techniques or in other situations in whichadjustable portion 404 may not be visible or connection of adjustableportion 404 to elongated member 104 may be difficult. In someembodiments, inner surface 464 may be configured by machining, such asby knurling, grooving, bead blasting, polishing, or the like, or coated,lined, or layered with material for connecting with elongated member104.

In some embodiments adjustable portion 404 may include transverseportion engaging member 416. In some embodiments, transverse portionengaging member 416 may be a ratchet to engage notches 442 for one waymovement of transverse portion 410.

In some embodiments, adjustable portion 404 may connect to elongatedmember 104 using various techniques and features. In some embodiments,adjustable portion 404 may connect to elongated member 104 due to asnap-fit, a compression fit, a sweat-locked fit, or the like. In someembodiments adjustable portion 404 may include connection member 424 toensure elongated member 104 remains connected to adjustable portion 404after implantation in the body. In some embodiments, connection member424 may include a piston, spring, cam, pin or threaded member. In someembodiments, connection member 424 may directly engage elongated member104, such as set screw 424 threadably engaging into adjustable portion404 depicted in FIG. 85A. In other words, in some embodiments, set screw424 may thread into adjustable portion 404 such that the end of setscrew 424 directly contacts a portion of elongated member 104 to preventelongated member 104 from disconnecting from adjustable portion 404. Insome embodiments, set screw 424 may thread into adjustable portion 404such that connection member 424 forms a barrier that indirectly preventsadjustable portion 404 from disconnecting from elongated member 104.

In some embodiments, transverse portion 410 may be in direct contactwith elongated member 104 such that threading set screw 424 intoadjustable portion 404 presses transverse portion 410 onto elongatedmember 104 to provide sufficient force to maintain transverse portion410 and elongated member 104 in a desired configuration.

In some embodiments, adjustable portion 404 may have an opening orthrough hole that allows the end of transverse portion 410 to enteradjustable portion 404. In some embodiments, the opening may be a cavity(not shown) to accommodate the end of transverse portion 410. In someembodiments, the opening may be a through hole allowing transverseportion 410 to pass through and protrude from adjustable portion 404.

Embodiments of the present disclosure may include mechanisms to preventor reduce the possibility of loosening or dislodging, either duringsurgery or thereafter, as desired. In some embodiments, the end oftransverse portion 410 may be widened to prevent it from uncoupling fromadjustable portion 404, by expanding the end such as by applying forceto deform the end (e.g., shaping or turning it to a ball or roundshape).

In some embodiments of the present disclosure, cross-link 400 may beconfigured to prevent elongated members 104 from diverging. FIG. 86depicts a perspective view of one embodiment of cross-link device 400useful for preventing elongated members 104 from diverging. In oneembodiment, cross-link 400 may have a generally inward-facingconfiguration (i.e., inner surface 466 of receiver portion 406 and innersurface 464 of adjustable portion 404 may be facing toward each other).In one embodiment, cross-link 400 may have a generally inward-facingconfiguration to prevent elongated members 104 from diverging onceimplanted in the body. In some embodiments, the surgeon may wish todesign converging elongated members 104 in order to accommodate aprogressively narrower spine.

In some embodiments, fixed portion 402 of cross-link device 400 mayinclude receiver portion 406 having an inner surface 466 for connectionwith elongated member 104 and transverse portion 410 for coupling toadjustable portion 404. In one embodiment the connection may besufficient to prevent disconnection but allow rotation and/or movementof fixed portion 402 along elongated member 104. In one embodiment theconnection may prevent any movement or rotation of fixed portion 402relative to elongated member 104. In some embodiments, fixed portion 402may include engaging member 408 for coupling fixed portion 402 toelongated member 104. In some embodiments, inner surface 466 of receiverportion 406 may be angular or curved to provide the desired contact withelongated member 104. For example, in some embodiments, inner surface466 may have an arc length or radius for contact with elongated member104 having a generally circular cross-sectional profile, or may bedefined by a length or width for contact with elongated member 104having a generally angular cross-section. In some embodiments, theconfiguration of inner surface 466 may facilitate connection toelongated member 104 using Minimally Invasive Surgery (MIS) techniquesor in other situations in which the receiver portion 406 may not bevisible or connection of the receiver portion 406 to elongated member104 may be difficult. In some embodiments, inner surface 466 may beconfigured by machining, such as by knurling, grooving, bead blasting,polishing, or the like, or coated, lined, or layered with material forselected contact with elongated member 104. In some embodiments,receiver portion 406 may connect to elongated member 104 using varioustechniques and features such that elongated member 104 may securelyconnect to receiver portion 406. In some embodiments, receiver portion406 may connect to elongated member 104 due to a snap-fit, a compressionfit, a sweat-locked fit, or the like. In some embodiments receiverportion 406 may include engaging member 408 to ensure elongated member104 remains coupled to receiver portion 406 once implanted in the body.In some embodiments, engaging member 408 may include a piston, spring,cam, pin or threaded member. In some embodiments, elongated memberengaging member 408 may indirectly engage elongated member 104, such asspring actuated linchpin 408. In other words, in some embodiments, aspring may advance linchpin 408 such that the end of linchpin 408 seatsin a cavity 434 or extends at least a selected depth such that a portionof linchpin 408 (i.e., the side) forms a barrier that prevents elongatedmember 104 from disconnecting from fixed portion 402.

In some embodiments, fixed portion 402 may include transverse portion410 fixedly connected to receiver portion 406 to enable cross-link 400to stabilize movement between elongated member 104 and elongated member104. In some embodiments, transverse portion 410 and receiver portion406 may be manufactured together as a single unit, or may bemanufactured separately and then joined using mechanical, chemical, orthermal methods, or some combination. For example, in some embodiments,transverse portion 410 may be threaded or compression fit to receiverportion 406. In some embodiments, transverse portion 410 may be glued orepoxied to receiver portion 406. In some embodiments, transverse portion410 may be welded or sweat-locked to receiver portion 406. In someembodiments, transverse portion 410 may have a solid cross section, ormay be cannulated. In some embodiments, transverse portion 410 may havea curved or angular cross-section. In some embodiments, thecross-section may be symmetric or asymmetric. In some embodiments,transverse portion 410 may be configured with one or more engagementfeatures along its length to facilitate coupling with adjustable portion404. In some embodiments, features on transverse portion 410 may besymmetric or otherwise allow for two-way adjustment, or may beasymmetric or otherwise allow only one-way adjustment. In FIG. 86,helically wound thread 442 along a portion of transverse portion 410 mayenable fixed portion 400 to couple with adjustable portion 404. Thoseskilled in the art will appreciate that the thread count, pitch, orother parameter of thread 442 on transverse portion 410 may be selectedbased on design, manufacturing, or surgical goals. Also, thread 442 maybe a continuous thread circumscribing transverse portion 410 or mayextend only about a selected radial portion of transverse portion 410.

In some embodiments, adjustable portion 404 may include an inner surface464 defined for connection with elongated member 104. In one embodimentthe connection may be sufficient to prevent disconnection but allowrotation and/or movement of adjustable portion 404 along elongatedmember 104. In one embodiment the connection may prevent any movement orrotation of adjustable portion 404 along elongated member 104. In someembodiments, adjustable portion 404 may include connection member 424.

In some embodiments, inner surface 464 of adjustable portion 404 may beangular or curved to provide the desired connection with elongatedmember 104. In some embodiments, inner surface 464 may be defined withan arc length or radius for connecting with elongated member 104 havinga generally circular cross-sectional profile. In some embodiments, innersurface 464 may be defined by a length or width for connecting withelongated member 104 having a generally angular cross-section. In someembodiments, the configuration of inner surface 464 may facilitateconnecting to elongated member 104 using Minimally Invasive Surgery(MIS) techniques or in other situations in which the receiver portion462 may not be visible or connection of the adjustable portion 404 toelongated member 104 may be difficult. In some embodiments, innersurface 464 may be configured by machining, such as by knurling,grooving, bead blasting, polishing, or the like, or coated, lined, orlayered with material for connecting with elongated member 104. In someembodiments, adjustable portion 404 may connect to elongated member 104using various techniques and features. In some embodiments, adjustableportion 404 may connect to elongated member 104 due to a snap-fit, acompression fit, a sweat-locked fit, or the like.

In some embodiments adjustable portion 404 may include connection member424 to ensure elongated member 104 remains coupled to adjustable portion404 once implanted in the body. In some embodiments, connection member424 may include a piston, pin, cam, spring or threaded member. In someembodiments, connection member 424 may directly engage elongated member104, such as connection member 424 depicted in FIG. 86. In other words,in some embodiments, connection member 424 may be inserted into aportion of adjustable portion 404 such that the end of connection member424 may be advanced to directly contact a portion of elongated member104 to prevent elongated member 104 from uncoupling from adjustableportion 404. In one embodiment, a canted surface 490 of wedge 424 mayapply a force on elongated member 104 normal to canted surface 490(i.e., having an axial component and a radial component) to maintainelongated member 104 in adjustable portion 404. Those skilled in the artwill appreciate that the angle of canted surface 490 may be selected toprovide a greater axial component or a greater radial component or equalcomponents.

In some embodiments, adjustable portion 404 may include transverseportion engaging member 416 to ensure adjustable portion 404 maysecurely couple to a portion of transverse portion 410. In someembodiments, transverse portion engaging member 416 may include threadedbearing 416 for engaging helically wound thread 442 on transverseportion 410. In some embodiments, transverse portion engaging member 416may be positioned internally or externally. In some embodiments, byrotating transverse portion engaging member 416, threads 442 ontransverse portion 410 may be engaged and transverse portion 410 mayadvance into or through adjustable portion 404.

In some embodiments, adjustable portion 404 may have an opening thatallows the end of transverse portion 410 to enter adjustable portion404. In some embodiments, the opening may be a cavity to accommodatetransverse portion 410. In some embodiments, the opening may be athrough hole allowing transverse portion 410 to pass through andprotrude from adjustable portion 404. In some embodiments, a spinestabilization system may include mechanisms to prevent or reduce thepossibility of loosening or dislodging, either during surgery orthereafter, as desired. In some embodiments, the end of transverseportion 410 may be widened after insertion to prevent it from uncouplingfrom adjustable portion 404, by expanding the end such as by applyingforce to deform the end (e.g., shaping or turning it to a ball or roundshape).

In some embodiments of the present disclosure, cross-link 400 may couplefixed portion 402 to adjustable portion 404 to prevent elongated members104 from converging. FIG. 87 depicts a side view of a cross-link device400 according to an illustrative embodiment of the disclosure. In oneembodiment, inner surface 466 of fixed portion 402 may be in a generallyoutward facing orientation and inner surface 464 of adjustable portion404 may be in a generally outward-facing orientation, resulting incross-link 400 having an outward-facing configuration. An outward-facingconfiguration may prevent elongated members 104 from converging oncecross-link 400 has been implanted in the body, but may still allow somedivergence.

In some embodiments, receiver portion 406 may be connectable toelongated member 104 using various techniques and features such thatfixed portion 402 remains coupled to elongated member 104. In someembodiments, fixed portion 402 may be connectable to elongated member104 using a snap-fit, a compression fit, a sweat-locked fit, or thelike.

In some embodiments, fixed portion 402 of cross-link 400 may includereceiver portion 406 having an inner surface 466 definable forconnection with elongated member 104. In one embodiment the selectivecontact may be sufficient contact to prevent disconnection but allowrotation and/or movement of fixed portion 402 along elongated member104. In one embodiment the selected contact may prevent any movement orrotation of fixed portion 402 relative to elongated member 104. In someembodiments, inner surface 466 of receiver portion 406 may be angular orcurved to connect with elongated member 104. For example, in someembodiments, inner surface 466 may be definable with an arc length orradius for connection with elongated member 104 having a generallycircular cross-sectional profile, or may be definable by a length orwidth for connection with elongated member 104 having a generallyangular cross-section. In some embodiments, the configuration of innersurface 466 may facilitate connection to elongated member 104 usingMinimally Invasive Surgery (MIS) techniques or in other situations inwhich receiver portion 406 may not be visible or connection of receiverportion 406 to elongated member 104 may be difficult. In someembodiments, inner surface 466 may be configured by machining, such asby knurling, grooving, bead blasting, polishing, or the like, or coated,lined, or layered with material for connection with elongated member104.

In some embodiments receiver portion 406 may include engaging member 408to connect fixed portion 402 to elongated member 104 once implanted inthe body. In some embodiments, engaging member 408 may include a piston,spring, cam, pin or threaded member. In some embodiments, engagingmember 408 may be configured to indirectly engage elongated member 104,such as spring-actuated piston 408 depicted in FIG. 87. In oneembodiment, a portion of elongated member 104 may enter receiver 406. Insome embodiments, as elongated member 104 encounters a selectedposition, a curved surface of elongated member 104 may push upward on acanted surface of engaging member 408. In some embodiments, a spring(such as spring 409), tang, viscoelastic material, or the like may becompressed to provide sufficient clearance such that elongated member104 may pass by into receiver portion 406. In some embodiments, onceelongated member 104 has passed a selected point, the spring, tang, orviscoelastic material may return to an original or neutral state due tothe travel of engaging member 408 on the curved surface of elongatedmember 104. In some embodiments, elongated member 104 may be captured byengaging member 408 directly contacting a portion of elongated member104, or engaging member 408 may be positioned to provide a barrier orinsufficient clearance for elongated member 104 to disconnect fromreceiver portion 406.

In some embodiments, to enable cross-link 400 to stabilize movementbetween elongated member 104 and elongated member 104, fixed portion 402may include transverse portion 410 fixedly connected to receiver portion406. In some embodiments, transverse portion 410 and receiver portion406 may be manufactured together as a single unit, or may bemanufactured separately and then joined using mechanical, chemical, orthermal methods, or some combination. In some embodiments, transverseportion 410 may be threaded or compression fit to receiver portion 406.In some embodiments, transverse portion 410 may be glued or epoxied toreceiver portion 406. In some embodiments, transverse portion 410 may bewelded or sweat-locked to receiver portion 406. In some embodiments,transverse portion 410 may have a solid cross section, or may becannulated. In some embodiments, transverse portion 410 may have acurved or angular cross-section. In some embodiments, the cross-sectionmay be symmetric or asymmetric. In some embodiments, transverse portion410 may be configured with one or more engagement features along aselected length to facilitate coupling with adjustable portion 404. Insome embodiments, transverse portion 410 may have a plurality ofengagement features, such as a series of holes, indentations, notches,ribs, or teeth configured for engagement with similar or complementaryfeatures in adjustable portion 404. In some embodiments, features ontransverse portion 410 may be symmetric or otherwise allow for two-wayadjustment, or may be asymmetric or otherwise allow only one-wayadjustment. In some embodiments, a portion of transverse portion 410 mayinclude rack 442 of teeth along a portion thereof to enable fixedportion 402 to couple with adjustable portion 404. Those skilled in theart will appreciate that the height, spacing, or other parameter of rack442 on transverse portion 410 may be selected based on design,manufacturing, or surgical methods. In some embodiments, rack 442 maycircumscribe transverse portion 410 or may extend only about a selectedradial portion of transverse portion 410.

In some embodiments, adjustable portion 404 may connect to elongatedmember 104 using various techniques and features. In some embodiments,adjustable portion 404 may connect to elongated member 104 due to asnap-fit, a compression fit, a sweat-locked fit, or the like. In someembodiments, adjustable portion 404 may have inner surface 464 definedfor connection with elongated member 104. In one embodiment theconnection may be sufficient to prevent disconnection but allow rotationand/or movement of adjustable portion 404 along elongated member 104. Inone embodiment the connection may prevent any movement or rotation ofadjustable portion 404 relative to elongated member 104. In someembodiments, inner surface 464 of adjustable portion 404 may be angularor curved to provide the connection with elongated member 104. In someembodiments, inner surface 464 may be definable with an arc length orradius for connection with elongated member 104 having a generallycircular cross-sectional profile. In some embodiments, inner surface 464may be definable by a length or width for connection with elongatedmember 104 having a generally angular cross-section. In someembodiments, the configuration of inner surface 464 may facilitateconnection to elongated member 104 using Minimally Invasive Surgery(MIS) techniques or in other situations in which adjustable portion 404may not be visible or connection of adjustable portion 404 to elongatedmember 104 may be difficult. In some embodiments, inner surface 464 maybe configured by machining, such as by knurling, grooving, beadblasting, polishing, or the like, or coated, lined, or layered withmaterial for connection with elongated member 104,

In some embodiments adjustable portion 404 may include connection member424 to ensure elongated member 104 remains coupled to adjustable portion404 once implanted in the body. In some embodiments, connection member424 may include a piston, pin, cam, spring or threaded member. In someembodiments, connection member 424 may directly engage elongated member104, such as by using clamp 424. In other words, a portion of elongatedmember 104 may be inserted into adjustable portion 404 having clamp 424.Clamp 424 may be configured to reduce adjustable portion 404 in diameterto connect to a portion of elongated member 104 such that adjustableportion 404 may directly contact a portion of elongated member 104 toprevent elongated member 104 from disconnecting from adjustable portion404.

In some embodiments, adjustable portion 404 may include transverseportion engaging member 416 for coupling with transverse portion 410. Inone embodiment, transverse portion engaging member 416 may be configuredsuch that only one-way rotation may be possible. Such rotation mayenable tightening of cross-link to adjust the system, but may preventdisconnection of the cross-link from elongated members 104. In someembodiments, transverse portion engaging member 416 may include a piniongear 416 positioned on adjustable portion 404 for engaging teeth on rack442 on transverse portion 410. In some embodiments, transverse portionengaging member 416 may be positioned internally. In some embodiments,by rotating transverse portion engaging member 416, teeth 442 ontransverse portion 410 may be engaged and transverse portion 410 may beadvanced into or through adjustable portion 404.

In some embodiments, adjustable portion 404 may have an opening thatallows transverse portion 410 to enter adjustable portion 404. In someembodiments, the opening may be a cavity to accommodate transverseportion 410. In some embodiments, the opening may be a through holeallowing transverse portion 410 to pass through and protrude fromadjustable portion 404. In some embodiments, a spinal stabilizationsystem may include mechanisms to prevent or reduce the possibility ofloosening or dislodging, either during surgery or thereafter, asdesired. In some embodiments, the end of transverse portion 410 may bewidened to prevent it from uncoupling from adjustable portion 404, byexpanding the end such as by applying force to deform the end (e.g.,shaping or turning it to a ball or round shape).

FIG. 88 depicts a posterior view of a portion of a spine in which anexemplary embodiment of a spine stabilization system has been implanted.In this embodiment, spine stabilization system 400 may be used tostabilize movement between two vertebrae (i.e., a one-levelstabilization). Spine stabilization system 400 may include elongatedmembers 104 coupled to a first portion of bone fastener assemblies 102.A second portion of bone fastener assemblies 102 may couple to a portionof a vertebral body. Fixed portion 402 may connect to a portion ofelongated member 104 and adjustable portion 404 may connect to a portionof elongated member 104. Adjustable portion 404 may further couple to aportion of transverse portion 410. In one embodiment, transverse portion410 may have a curved, bent, or angled shape to avoid or accommodate aspinous process. In one embodiment, the placement of bone fastenerassemblies 102 and elongated members 104 may have resulted in a straighttransverse portion penetrating, touching, or otherwise interfering withthe range of motion for a vertebra. Curved transverse portion 410 mayenable the surgeon to couple bone fastener assemblies 102 and elongatedmembers 104 in any selected part of spine 10 without fear of interferingwith movement of the spine. This may result in a less complicatedsurgical procedure, a more robust stabilization system, less pain forthe patient, and better motion for the patient.

The spine stabilization systems according to the disclosure, includingthe cross-link devices (or poly-axial connectors) may be used inminimally invasive surgery (MIS) procedures or in non-MIS procedures, asdesired, and as persons of ordinary skill in the art who have thebenefit of the description of the disclosure understand. MIS proceduresseek to reduce cutting, bleeding, and tissue damage or disturbanceassociated with implanting a spinal implant in a patient's body.Exemplary procedures may use a percutaneous technique for implantingelongated members and coupling elements. Further examples of MISprocedures and related apparatus can be found in U.S. patent applicationSer. No. 10/698,049, filed Oct. 30, 2003, U.S. patent application Ser.No. 10/698,010, Oct. 30, 2003, and U.S. patent application Ser. No.10/697,793, filed Oct. 30, 2003, incorporated herein by reference.

The variable cross-link devices according to the disclosure are suitablefor use with MIS procedures because engaging member 408, transverseportion engaging member 416, and connection member 424 may be actuatedfrom above using MIS tools. In such an MIS procedure, the surgeon maypercutaneously position and place the implant using the same techniqueand through the same wound exposure as with other spinal implants.

In some embodiments, implanting cross-link devices may not entailadditional exposures or cuts, as all insertion and locking of thepoly-axial connector may be performed through existing exposure sitesused to implant the elongated members. In some embodiments, implantingvariable length cross-links 400 may be accomplished by guiding thedevice through an additional incision or wound lateral to the spinalfixation site and into position with a wire, rod or the like.

FIG. 89 depicts a superior view of a spinal implantation in a patient'sbody in which guide wire 500 may be used to guide fixed portion 402 andadjustable portion 404 to stabilize motion between elongated members104. A guide wire generally refers to a piece of medical equipmenthaving selected width, diameter, or gauge useful to create a pathway ina body. A guide wire may have a generally symmetric and constantcross-section throughout its length. A guide wire may have an asymmetricportion extending at least a portion of its length. A guide wire mayhave a variable cross-section extending at least a portion of itslength. In some embodiments, guide wire 500 may be identical to guidewire 218 depicted in FIGS. 22 and 23.

In some embodiments, guide wire 500 may be inserted at a point lateralto the spinal column and advanced into the body to create a path passingnear a portion of the spine 10. In FIG. 89, wounds W₁ and W₂ representincisions that may be used to insert at least a portion of guide wire500 into a patient. In some embodiments, guide wire 500 may be insertedin one or more incisions and may pass over or under one or moreelongated members. In some embodiments, wire 500 may be inserted intothe patient at W₁ at some angle (alpha) and advanced to pass underelongated members 104 such that wire 500 may be positioned betweenelongated members 104 and the spine. Fixed portion 402 having acannulated receiver portion 406 and transverse portion 410 or both maybe positioned on guide wire 500 and advanced into the patient using wire500.

In some embodiments, wire 500 remains stationary once inserted into thebody and fixed portion 402 or adjustable portion 404 or both may beadvanced by pushing with a tool. In some embodiments, a tool may be usedto pull fixed portion 402 adjustable portion 404, or both along wire500. In some embodiments, wire 500 has one or more features useful forindicating when fixed portion 402 or adjustable portion 404 or both areproperly positioned. In some embodiments, fixed portion 402 oradjustable portion 404 or both may be detachably connected to a portionor feature of wire 500 and wire 500 may be advanced or withdrawn toposition fixed portion 402 or adjustable portion 404 or both.

In some embodiments, fixed portion 402 or adjustable portion 404 or bothmay be advanced until a portion of fixed portion 402 or adjustableportion 404 or both contacts an anatomical landmark or a portion ofelongated member 104 or otherwise indicates fixed portion 402 may bepositioned for coupling to elongated member 104. In some embodiments,wire 500 may be advanced or withdrawn until features or markings on wire500 indicate fixed portion 402 or adjustable portion 404 or both areproperly positioned. In some embodiments, wire 500, fixed portion 402 oradjustable portion 404 or all may be visible to a surgeon lookingthrough sleeve 244 or dilator positioned at the attachment site. In someembodiments, a tool (not shown) useful for connecting fixed portion 402to elongated member 104 may be used to properly position fixed portion402 relative to elongated member 104. Portions of cross-link 400 may bepositioned over or under elongated member 104.

Fixed portion 402 may connect to elongated member 104 using engagingmember 408 mentioned above, or some other direct or indirect couplingmechanism. In some embodiments engaging member 408 may be threaded intoa position such that there may be insufficient clearance to allowelongated member 104 to disconnect. In one embodiment, a spring-actuatedmechanism may provide sufficient force to engage elongated member 104directly, or may actuate a linchpin to prevent elongated member 104 fromdisconnecting from fixed portion 402.

Before, after, or simultaneously with the insertion of a fixed portion402 into the body, an adjustable portion 404 may also be inserted andadvanced into the body. In some embodiments, the adjustable portion 404may be cannulated such that wire 500 may be used to advance adjustableportion 404 into position. In some embodiments, wire 500 may be a singlewire and both fixed portion 402 and adjustable portion 404 may be pushedinto position using other tools. In some embodiments, wire 500 may beconfigured to advance either fixed portion 402 or adjustable portion 404into position.

For example, wire 500 may have a flange 523 with legs 524 configured fordetachable connection to fixed portion 402 such that by advancing andselectively rotating wire 500, fixed portion 402 may connect to aportion of elongated member 104. In one embodiment, wire 500 may have aflange (not shown) with legs configured to capture adjustable portion404 such that by advancing and selectively rotating wire 500, adjustableportion 404 may connect to a portion of elongated member 104.

In some embodiments, wire 500 may have two or more components. FIG. 90Adepicts a cross-section view of one embodiment in which wire 500 mayhave a first component 505 with a cross-sectional profile and dimensionsto allow passage through a second component 506 with a secondcross-sectional profile and dimensions. In one embodiment, firstcomponent 505 may be inserted at a first wound W₁ and advanced throughthe implantation site to second wound W₂. A second component 506 may beinserted on either end of the first component 505 or both ends, andfixed portion 402 or adjustable portion 404 or both may be advanced tothe implantation site. For purposes of this document, an implantationsite refers to a general position on a spine that has two or more bonefasteners 108 implanted in bony tissue and elongated member 104connecting bone fasteners 108.

One example of how first component 505 and second component 506 may beuseful for connecting fixed portion 402 and adjustable portion 404 mayinvolve the use of teeth or gears (not shown) on the end of secondcomponent 506 to engage and rotate a gear such as transverse portionengaging member 416 depicted in FIG. 86. In this embodiment, firstcomponent 505 of wire 500 may be inserted into the patient andpositioned and configured near the implantation site. Fixed portion 402and adjustable portion 404 may be inserted and advanced along firstcomponent 505 and aligned for coupling. Second component 506 may beinserted and advanced along first component 505 until teeth on the endof second component 506 contact and mesh with teeth on a gear such asthreaded bearing 416. Second component 506 may be rotated such thatthreaded bearing 416 rotates to engage and advance a transverse portionsuch as transverse portion 410 having helical thread 442 depicted inFIG. 86. Continued rotation of component 506 may result in transverseportion 410 advancing such that a selected length or spacing may beachieved between first and second elongated members 104. Secondcomponent 506 may then be disengaged from threaded bearing 416 andwithdrawn from the body. First component 505 may be withdrawn from thebody, leaving cross-link 400 coupled to first and second elongatedmembers 104.

FIG. 90B depicts a cross-sectional view of one embodiment of amulti-part wire in which a first component 507 may be slidablyconnected, such as by a track and groove, to a second component 508.Using this embodiment, first component 507 may be configured, such aswith a rail, tab, flange, groove, or other feature 509 for selectedcontact with fixed portion 402, adjustable portion 404, or both, andsecond component 508 may be configured, such as with a rail, tab,flange, groove, or other feature 510 for selected contact with fixedportion 402, adjustable portion 404, or both, without interfering witheach other.

One example of how features 509 and 510 may be useful for connectingfixed portion 402 and adjustable portion 404 may involve the use offlanges to advance fixed portion 402 and adjustable portion 404 intoposition. Assuming wire 500 may be inserted and oriented near theimplantation site, fixed portion 402 may be positioned on firstcomponent 507 with feature 509 positioned anterior such that pulling theopposite end of component 507 pulls feature 509 against fixed portion402 such that fixed portion 402 advances along wire 500 to theimplantation site. Similarly, adjustable portion 404 may be positionedon second component 508 with feature 510 positioned anterior such thatpulling the opposite end of second component 508 pulls feature 510against adjustable portion 404 such that adjustable portion 404 advancesto the implantation site. Continued pulling on both ends 507 and 508 ofwire 500 may result in transverse portion 410 coupling to adjustableportion 404, due to the general profile of wire 500, as well as firstcomponent 507 and second component 508 individually.

FIGS. 91A, 91B, and 91C depict views of one embodiment of a portion of aspinal fixation system illustrating a method for advancing the systemusing sleeves 244. For simplicity purposes, portions of the spinalfixation system may not be visible. In some embodiments a sleeve such assleeve 244 may attach to a portion of adjustable portion 404 forpositioning adjustable portion 404 on elongated member 104. In someembodiments a tool (not shown) may be inserted in central bore 908 ofsleeve 244 to configure adjustable portion 404, such as tightening a setscrew to connect adjustable portion 404 to elongated member 104 or 102.In some embodiments, end 944 of transverse portion 410 may extendthrough adjustable portion 404. In some embodiments, sleeve 244 has acentral bore 908 formed in a continuous outer surface. In someembodiments, sleeve 244 may have holes 905, slots 901, 903, 907 or 909,or combinations 905. Those skilled in the art will appreciate that theposition, length, width, depth, orientation, or other dimension may beselected based on surgical methods, patient health, surgeon preferences,or the like. In some embodiments, slot 907 may be formed to enable asurgeon to have access to the patient throughout the length of sleeve244.

In some cases, the surgeon may need or want to access a part of the bodyother than at the surface or at the implantation site. In someembodiments, slot 903 may allow for visual inspection. In someembodiments, slot 901 may provide clearance for a tool (not shown). Insome embodiments, slot 909 may provide access only at selected points.In some embodiments a slot or a combination of features forming a slot905 may provide attachment points for a surgical tool (not shown). Insome embodiments, slot 905 may be a combination of an angular portionjoined with a circular portion. In some embodiments, the circularportion may be threaded. In some embodiments, slot 905 may attach to aportion of a surgical tool (not shown).

FIGS. 92A and 92B depict views of a system useful for positioningportions of a spinal fixation system. FIG. 92A depicts a view of sleeve244 for positioning and connection with an adjustable portion 404.Positioning tool 1003 may be useful for positioning adjustable portion404 or a fixed portion (not shown). In one embodiment, positioning tool1003 includes a stationary portion 1002 and internal shaft 1004. Movinginternal shaft 1004 up or down may actuate lever 1006 to rotate up ordown for positioning a portion of a spinal fixation system. In someembodiments, lever 1006 may be rigid. In some embodiments lever 1006 maybe semi-rigid. In some embodiments, lever 1006 may be flexible. In someembodiments, lever 1006 may have distal end 1008 for attachment to aportion of a spinal fixation system. Lever 1006 may include asharp-edged tool useful for cutting or separating tissue fibers tofacilitate positioning or implantation.

Embodiments of the present disclosure may enable a surgeon to connectfixed portion 402 to elongated member 104, adjustable portion 404 toelongated member 104, and couple transverse portion 410 to adjustableportion 404 in any order. In some embodiments, fixed portion 402 may beinserted in the body and connected to elongated member 104, adjustableportion 404 may be inserted in the body and connected to elongatedmember 104, and then adjustable portion 404 may be coupled to transverseportion 410 to provide a selected length or spacing between elongatedmembers 104. Alternatively, in some embodiments, fixed portion 402 maybe inserted in the body and attached to elongated member 104, adjustableportion 404 may be inserted in the body and coupled to transverseportion 410 to provide a selected length or spacing between elongatedmembers 104, and then adjustable portion 404 may be connected toelongated member 104. In some embodiments, adjustable portion 404 may beinserted in the body and connected to elongated member 104, fixedportion 402 may be inserted in the body and transverse portion 410 maybe coupled to adjustable member 404 to provide a selected length orspacing between elongated members 104, and then fixed portion 402 may beconnected to elongated member 104. Alternatively, in some embodiments,adjustable portion 404 may be inserted in the body and attached toelongated member 104, fixed portion 402 may be inserted in the body andconnected to elongated member 104, and then adjustable portion 404 maybe coupled to transverse portion 410 to provide a selected length orspacing between elongated members 104.

In some embodiments, fixed portion 402 and adjustable portion 404 may becoupled outside the body and then inserted and connected to the firstand second elongated members. The order of insertion and connection maybe based on several factors, including the positioning or orientation ofthe guide wire, one or more components of the variable lengthcross-link, surgical preferences, patient health, or the like.

FIGS. 93A and 93B depict side and top views of a system useful forpositioning cross-links 400 along a spine. In some embodiments,adjustable portion 404 may be inserted and attached to elongated member104 using sleeve 244 such as sleeve 1000. In some embodiments, fixedportion 402 may be insertable into the body by first connectingtransverse portion end 1044 with lever end 1008 and then advancing theconstruct as a single unit. In some embodiments, fixed portion 402 maybe inserted into the body, distal end 1008 of tool 1003 may be insertedinto the body, and then transverse portion end 1044 may connect todistal end 1008 inside the body. In some embodiments, fixed portion 402may be inserted in the body by passing fixed portion 402 down a centralbore such as central bore 908 of sleeve 244 depicted in FIG. 10A. Insome embodiments, fixed portion 402 and/or distal end 1003 may beinserted into the body using a guide wire such as guide wire 500depicted in FIG. 90 or guide wire 218 depicted in FIGS. 22 and 23.

FIG. 94 depicts a side view of one embodiment of a system useful forimplanting portions of a spinal stabilization system. In someembodiments, withdrawing tool 1003 from the body may rotate and/orposition fixed portion 1022 such that end 1044 may advance intoadjustable portion 404. In one embodiment, further pulling on tool 1003may pull one elongated member 104 closer to another elongated member104. In some embodiments, the process of pulling transverse portion 410into adjustable portion 404 may result in sufficient configurationand/or contact to prevent disconnection from elongated members 104. Insome embodiments, once transverse portion 410 advances into a portion ofadjustable portion 404, a transverse portion engaging member (not shown)may engage one or more features or gradations on transverse portion 410to maintain a selected length of the variable length cross-link. Atransverse portion engaging member may be attachable to adjustableportion 404 before insertion into the body or may pass through sleeve244 and attach to adjustable portion 404.

Once the adjustable portion has been connected to the transverseportion, sleeves 244, guide wires 218, and other tools may be withdrawnfrom the body and the assembled cross-link 400 may retain elongatedmembers 104 in a selected configuration to facilitate spinal fixation.

In some embodiments, transverse portion engaging member 416 may beconfigured to facilitate adjustment after implantation. For example, insome embodiments a surgeon may treat a patient by adjusting the spinefixation system in steps as opposed to a more aggressive realignmentprocess. Embodiments of the present disclosure may be adjusted afterimplantation to allow the surgeon such an option. In some embodiments,engagement features on transverse portion 410 may allow the surgeon tocontrol the adjustment. In some embodiments, notches 442 or otherfeatures 442 located along transverse portion 410 provide discreteadjustment points. In some embodiments, a helically wound thread 442provides a continuous set of adjustment points. A spinal fixation systemthat allows the surgeon to make controlled adjustments to a cross-linkmay provide more comfort, less pain, and an easier recovery for thepatient without sacrificing spinal stabilization.

The foregoing specification and accompanying figures are for the purposeof teaching those skilled in the art the manner of carrying out thedisclosure and should be regarded in an illustrative rather than arestrictive sense. As one skilled in the art can appreciate, embodimentsdisclosed herein can be modified or otherwise implemented in many wayswithout departing from the spirit and scope of the disclosure and allsuch modifications and implementations are intended to be includedwithin the scope of the disclosure as set forth in the claims below.

1. A cross-link device, comprising: a fixed portion sized to be guidedthrough a first incision to a first elongated member positioned on afirst side of the spine, wherein the fixed portion comprises atransverse portion and a receiver portion, wherein the transverseportion is shaped to extend perpendicularly to the first elongatedmember and sized to span a distance between the first elongated memberand a second elongated member positioned on a second side of the spine,wherein the receiver portion of the fixed portion is shaped to connectto the first elongated member; and an adjustable portion sized to beguided through a second incision to the second elongated memberpositioned on the second side of the spine, wherein the adjustableportion comprises a passage and a receiver portion, wherein the passageis adapted to accept the transverse portion of the fixed portion,wherein the receiver portion of the adjustable portion is shaped toconnect to the second elongated member, wherein the transverse portionand the adjustable portions are configured to securely couple to theadjustable portion at a location between the first and second incisions.2. A cross-link device according to claim 1, wherein the fixed portionis further configured to connect to a distal end of an extender.
 3. Across-link device according to claim 1, wherein the fixed portion isfurther configured to threadably engage a distal end of a positioningtool.
 4. A cross-link device according to claim 1, wherein the fixedportion further comprises one or more engagement features for engagingthe adjustable portion.
 5. A cross-link device according to claim 4,wherein the one or more engagement features comprises a helically woundthread on the transverse portion of the fixed portion.
 6. A cross-linkdevice according to claim 5, wherein the adjustable portion furthercomprises a bearing, the bearing having a thread that is complementaryto the helically wound thread on the transverse portion of the fixedportion.
 7. A cross-link device according to claim 4, wherein the one ormore engagement features comprises a series of notches on the transverseportion of the fixed portion.
 8. A cross-link device according to claim7, wherein the adjustable portion further comprises a ratchet, theratchet being configured to engage one or more of the series of notcheson the transverse portion of the fixed portion.
 9. A cross-link deviceaccording to claim 4, wherein the one or more engagement featurescomprises a series of teeth on the transverse portion of the fixedportion.
 10. A cross-link device according to claim 9, wherein theadjustable portion further comprises a gear, the gear being configuredto mesh with one or more of the teeth on the transverse portion of thefixed portion.
 11. A cross-link device according to claim 1, wherein thefixed portion further comprises a cannulated passage sized to receive aguide wire.
 12. A cross-link device according to claim 11, wherein theguide wire comprises one or more features for engaging the fixedportion.
 13. A cross-link device according to claim 11, wherein theadjustable portion further comprises a cannulated passage sized toreceive the guide wire.
 14. A cross-link device according to claim 1,wherein the adjustable portion is further configured to connect to adistal end of a sleeve.
 15. A cross-link device according to claim 1,wherein the adjustable portion is further configured to threadablyengage a distal end of a sleeve.
 16. A cross-link device according toclaim 1, wherein the adjustable portion further comprises a connectionmember.
 17. A cross-link device according to claim 16, wherein theconnection member of the adjustable portion comprises a tool portionconfigured to connect to a driver.
 18. A wire-guided system orstabilizing a portion of a spine using percutaeous procedures,comprising: a first elongated member; a second elongated member; and across-link device, comprising: a fixed portion sized to be guidedthrough a first incision to the first elongated member positioned on afirst side of the spine, wherein the fixed portion comprises atransverse portion and a receiver portion, wherein the transverseportion is shaped to extend perpendicularly to the first elongatedmember and sized to span a distance between the first elongated memberand the second elongated member positioned on a second side of thespine, wherein the receiver portion of the fixed portion is shaped toconnect to the first elongated member; and an adjustable portion sizedto be guided through a second incision to the second elongated memberpositioned on the second side of the spine, wherein the adjustableportion comprises a passage and a receiver portion, wherein the passageis adapted to accept the transverse portion of the fixed portion,wherein the receiver portion of the adjustable portion is shaped toconnect to the second elongated member, wherein the transverse portionand the adjustable portions are configured to securely couple to theadjustable portion at a location between the first and second incisions.19. A wire-guided system according to claim 18, further comprising: aguide wire, wherein the fixed portion further comprises a cannulatedpassage sized to receive the guide wire and wherein the adjustableportion further comprises a cannulated passage sized to receive theguide wire.
 20. A wire-guided system according to claim 18, furthercomprising: a sleeve, wherein the adjustable portion is furtherconfigured to connect to a distal end of the sleeve.